Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41235   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy Comparison of Ivermectin 1% Topical Cream Associated with Doxycycline 40 mg Modified release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated with Placebo in the Treatment of Severe Rosacea

    Summary
    EudraCT number
    2017-000157-40
    Trial protocol
    HU   DE   CZ   PL  
    Global end of trial date
    08 Feb 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Mar 2021
    First version publication date
    11 Mar 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    RD.03.SPR.113322
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03075891
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GALDERMA R&D SNC
    Sponsor organisation address
    Les Templiers, 2400 Route des Colles, Biot, France, 06410
    Public contact
    CTA Coordinator, GALDERMA R&D SNC, +33 (0)493 95 70 85, cta.coordinator@galderma.com
    Scientific contact
    CTA Coordinator, GALDERMA R&D SNC, +33 (0)493 95 70 85, cta.coordinator@galderma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (DMR) capsules versus IVM monotherapy in the treatment of severe rosacea.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles from the Declaration of Helsinki revised version (Somerset West, 1996), the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and in compliance with local regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jul 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 54
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    Czech Republic: 44
    Country: Number of subjects enrolled
    Denmark: 41
    Country: Number of subjects enrolled
    Hungary: 60
    Country: Number of subjects enrolled
    Poland: 57
    Worldwide total number of subjects
    273
    EEA total number of subjects
    202
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    219
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    This study was conducted at 39 sites in Canada, Czech Republic, Germany, Hungary, Poland, and United States of America between 05 July 2017 to 08 February 2018.

    Pre-assignment
    Screening details
    A total of 273 subjects were randomized and treated, out of which 251 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind [1]
    Roles blinded
    Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules
    Arm description
    Ivermectin 1 percent (%) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 milligram (mg) Modified Release (MR) (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 capsule once-daily for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ivermectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects applied ivermectin 1% cream topically once a day for 12 weeks.

    Investigational medicinal product name
    Doxycycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received doxycycline 40 mg MR (30 mg immediate release & 10 mg delayed release beads) capsule orally once-daily for 12 weeks.

    Arm title
    Ivermectin 1% Cream + Oral Placebo Capsules
    Arm description
    Ivermectin 1% cream: topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 capsule once-daily for 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Ivermectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects applied ivermectin 1% cream topically once a day for 12 weeks.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo capsule matching to doxycycline 40 mg MR orally once-daily for 12 weeks.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This study was designed as investigator-blinded.
    Number of subjects in period 1
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Started
    135
    138
    Completed
    126
    125
    Not completed
    9
    13
         Drug abuse relapse issue
    -
    1
         Patient requiring study withdrawal
    -
    1
         Pregnancy
    3
    1
         Adverse event, non-fatal
    1
    4
         Consent withdrawn by subject
    3
    6
         visits not performed (no time)
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules
    Reporting group description
    Ivermectin 1 percent (%) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 milligram (mg) Modified Release (MR) (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 capsule once-daily for 12 weeks.

    Reporting group title
    Ivermectin 1% Cream + Oral Placebo Capsules
    Reporting group description
    Ivermectin 1% cream: topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 capsule once-daily for 12 weeks.

    Reporting group values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules Total
    Number of subjects
    135 138 273
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    109 110 219
        From 65-84 years
    26 28 54
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.4 ± 13.5 51.6 ± 13.3 -
    Gender categorical
    Units: Subjects
        Female
    75 80 155
        Male
    60 58 118
    Skin Phototype
    Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly; skin phototype IV = light brown skin, burns minimally, always tans well; skin phototype V = brown skin, rarely burns, tans profusely; skin phototype VI = dark brown or black skin, never burns, tans profusely.
    Units: Subjects
        Skin phototype I
    5 11 16
        Skin phototype II
    82 83 165
        Skin phototype III
    37 38 75
        Skin phototype IV
    8 6 14
        Skin phototype V
    1 0 1
        Skin phototype VI
    2 0 2

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules
    Reporting group description
    Ivermectin 1 percent (%) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 milligram (mg) Modified Release (MR) (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 capsule once-daily for 12 weeks.

    Reporting group title
    Ivermectin 1% Cream + Oral Placebo Capsules
    Reporting group description
    Ivermectin 1% cream: topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 capsule once-daily for 12 weeks.

    Primary: Percent Change From Baseline in Inflammatory Lesion Count at Week 12

    Close Top of page
    End point title
    Percent Change From Baseline in Inflammatory Lesion Count at Week 12
    End point description
    Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is [i.e.] papules and pustules) which were defined as follows: Papule – a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule – a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. Intent-to-treat (ITT) population consisted of the entire population enrolled and randomized. The last observation carried forward (LOCF) method was used to impute missing values for inflammatory lesion count.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percent change
        arithmetic mean (standard deviation)
    -80.29 ± 21.65
    -73.56 ± 30.52
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules v Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.032
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8

    Close Top of page
    End point title
    Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8
    End point description
    Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule – a small, solid elevation less than 1.0 centimeter in diameter. Pustule – a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4 and 8
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 4
    -48.15 ± 26.71
    -39.27 ± 27.93
        Week 8
    -69.14 ± 24.10
    -61.44 ± 28.74
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clear Inflammatory Lesions at Week 12

    Close Top of page
    End point title
    Percentage of Subjects with Clear Inflammatory Lesions at Week 12
    End point description
    Percentage of subjects with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule – a small, solid elevation less than 1.0 cm in diameter. Pustule – a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of subjects
        number (not applicable)
    17.8
    7.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Percentage of Subjects With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12
    End point description
    Percentage of subjects with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule – a small, solid elevation less than 1.0 centimeter in diameter. Pustule – a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subjects
    number (not applicable)
        Week 4: Yes
    1.5
    0.0
        Week 4: No
    98.5
    100.0
        Week 8: Yes
    5.2
    2.9
        Week 8: No
    94.8
    97.1
        Week 12: Yes
    17.8
    7.2
        Week 12: No
    82.2
    92.8
    No statistical analyses for this end point

    Secondary: Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12
    End point description
    The evaluator assessed the subject’s diffuse persistent facial erythema of rosacea by performing a static (“snap shot”) evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 4
    2.47 ± 0.94
    2.56 ± 0.94
        Week 8
    1.85 ± 0.95
    1.97 ± 0.94
        Week 12
    1.51 ± 1.02
    1.58 ± 0.95
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Percentage of Subjects in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12
    End point description
    The percentage of subjects in each clinician’s erythema assessment score category was reported. The evaluator assessed the subject’s diffuse persistent facial erythema of rosacea by performing a static (“snap shot”) evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (0= Clear skin)
    0.7
    0.7
        Week 4 (1= Almost clear)
    16.3
    12.3
        Week 4 (2= Mild erythema)
    31.9
    34.1
        Week 4 (3= Moderate erythema)
    37.8
    36.2
        Week 4 (4= Severe erythema)
    13.3
    16.7
        Week 8 (0= Clear skin)
    5.2
    1.4
        Week 8 (1= Almost clear)
    31.1
    33.3
        Week 8 (2= Mild erythema)
    43.7
    39.1
        Week 8 (3= Moderate erythema)
    13.3
    18.8
        Week 8 (4= Severe erythema)
    6.7
    7.2
        Week 12 (0= Clear skin)
    14.1
    7.2
        Week 12 (1= Almost clear)
    41.5
    47.8
        Week 12 (2= Mild erythema)
    28.1
    29.7
        Week 12 (3= Moderate erythema)
    11.9
    10.1
        Week 12 (4= Severe erythema)
    4.4
    5.1
    No statistical analyses for this end point

    Secondary: Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12
    End point description
    The evaluator assessed the subject’s rosacea by performing a static (“snap shot”) evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 4
    2.59 ± 0.88
    2.84 ± 0.83
        Week 8
    1.78 ± 0.83
    2.04 ± 0.93
        Week 12
    1.34 ± 0.89
    1.57 ± 0.95
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Percentage of Subjects in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12
    End point description
    The percentage of subjects in each Investigator’s Global Assessment (IGA) score category was reported. The evaluator assessed the subject’s rosacea by performing a static (“snap shot”) evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subject
    number (not applicable)
        Week 4 (0 - Clear)
    1.5
    0.7
        Week 4 (1 - Almost clear)
    11.1
    5.1
        Week 4 (2- Mild)
    25.2
    23.9
        Week 4 (3 - Moderate)
    51.9
    50.0
        Week 4 (4 - Severe)
    10.4
    20.3
        Week 8 (0 - Clear)
    3.0
    3.6
        Week 8 (1 - Almost clear)
    34.8
    22.5
        Week 8 (2 - Mild)
    48.1
    47.8
        Week 8 (3 - Moderate)
    9.6
    18.1
        Week 8 (4 - Severe)
    4.4
    8.0
        Week 12 (0 - Clear)
    11.9
    5.1
        Week 12 (1 - Almost clear)
    54.8
    54.3
        Week 12 (2 - Mild)
    24.4
    26.1
        Week 12 (3 - Moderate)
    5.2
    8.0
        Week 12 (4 - Severe)
    3.7
    6.5
    No statistical analyses for this end point

    Secondary: Stinging/Burning Severity Score at at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Stinging/Burning Severity Score at at Weeks 4, 8 and 12
    End point description
    The evaluator recorded the severity of the subject’s facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 4
    0.73 ± 0.79
    0.65 ± 0.75
        Week 8
    0.41 ± 0.64
    0.44 ± 0.67
        Week 12
    0.31 ± 0.55
    0.33 ± 0.63
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12

    Close Top of page
    End point title
    Percentage of Subjects in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12
    End point description
    The percentage of subjects in each stinging/burning severity score category was reported. The evaluator recorded the severity of the subject’s facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8 and 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subjects
    number (not applicable)
        Week 4 (0 - None)
    47.4
    50.0
        Week 4 (1 - Mild)
    32.6
    36.2
        Week 4 (2 - Moderate)
    19.3
    12.3
        Week 4 (3 - Severe)
    0.7
    1.4
        Week 8 (0 - None)
    67.4
    64.5
        Week 8 (1 - Mild)
    24.4
    28.3
        Week 8 (2 - Moderate)
    8.1
    5.8
        Week 8 (3 - Severe)
    0.0
    1.4
        Week 12 (0 - None)
    73.3
    75.4
        Week 12 (1 - Mild)
    22.2
    17.4
        Week 12 (2 - Moderate)
    4.4
    6.5
        Week 12 (3 - Severe)
    0.0
    0.7
    No statistical analyses for this end point

    Secondary: Global Improvement Total Score at Week 12 (Last Visit/Early Termination)

    Close Top of page
    End point title
    Global Improvement Total Score at Week 12 (Last Visit/Early Termination)
    End point description
    Subjects were evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. It is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). ITT population consisted of the entire population enrolled and randomized. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    126
    129
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.79 ± 1.20
    1.81 ± 1.20
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination)

    Close Top of page
    End point title
    Percentage of Subjects in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination)
    End point description
    Subjects were to evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. it is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved [100% improvement]); 1=excellent improvement (nearly all signs and symptoms cleared [90% improvement]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved [about 75% improvement]); 3=good improvement (significant improvement, but many signs and symptoms remain [about 50% improvement]); 4=minimal improvement (slight overall improvement, but not clinically significant [about 25% improvement]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). ITT population consisted of the entire population enrolled and randomized. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    126
    129
    Units: Percentage of Subjects
    number (not applicable)
        0 - Complete improvement
    7.9
    6.2
        1 - Excellent improvement
    39.7
    44.2
        2 - Very good improvement
    31.7
    25.6
        3 - Good improvement
    11.9
    15.5
        4 - Minimal improvement
    4.0
    3.9
        5 - No change
    4.0
    3.9
        6 - Worse
    0.8
    0.8
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Close Top of page
    End point title
    Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Safety population (all patients treated [APT]) – consisted of the ITT population, after exclusion of subjects who never used the treatment with certainty based on monitoring report.
    End point type
    Secondary
    End point timeframe
    From the signing of the informed consent form (ICF) up to Week 12
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Subjects
        AEs
    27
    50
        SAEs
    1
    1
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)

    Close Top of page
    End point title
    Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)
    End point description
    DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging, 2) how embarrassed/self-conscious, 3) interfere shopping or looking after home or garden, 4) Influence clothes, 5) affect social/leisure activity, 6) difficult to do sport, 7) prevent from working/studying or If no, problem at work/studying, 8) problem with partner or close friend, 9) cause sexual difficulties, 10) problem caused by treatment. Total score ranged from 0-30,where,0-1=no effect at all on life;2-5=small effect on life; 6-10=moderate effect on life;11-20=very large effect on life;21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. ITT population consisted of the entire population enrolled and randomised.Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    125
    129
    Units: Units on a scale
        arithmetic mean (standard deviation)
    1.4 ± 2.2
    2.2 ± 4.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category

    Close Top of page
    End point title
    Percentage of Subjects in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category
    End point description
    DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging, 2) how embarrassed/self-conscious, 3) interfere shopping or looking after home or garden, 4) Influence clothes, 5) affect social/leisure activity, 6) difficult to do sport, 7) prevent from working/studying or If no, problem at work/studying, 8) problem with partner or close friend, 9) cause sexual difficulties, 10) problem caused by treatment. Total score ranged from 0-30,where,0-1=no effect at all on life;2-5=small effect on life; 6-10=moderate effect on life;11-20=very large effect on life;21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. ITT population consisted of the entire population enrolled and randomised. Here 'n' (number analyzed) signifies number of subject evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subjects
    number (not applicable)
        Baseline: 0-1 (n=135,138)
    17.8
    18.8
        Baseline: 2-5 (n=135,138)
    37.8
    33.3
        Baseline: 6-10 (n=135,138)
    27.4
    32.6
        Baseline: 11-20 (n=135,138)
    14.8
    12.3
        Baseline: 21-30 (n=135,138)
    2.2
    2.9
        Last visit: 0-1 (n=125,129)
    68.0
    65.1
        Last visit: 2-5 (n=125,129)
    26.4
    24.0
        Last visit: 6-10 (n=125,129)
    4.8
    7.0
        Last visit: 11-20 (n=125,129)
    0.8
    3.1
        Last visit: 21-30 (n=125,129)
    0.0
    0.8
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/ Early Termination)

    Close Top of page
    End point title
    Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/ Early Termination)
    End point description
    DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging, 2) how embarrassed/self-conscious, 3) interfere shopping or looking after home or garden, 4) Influence clothes, 5) affect social/leisure activity, 6) difficult to do sport, 7) prevent from working/studying or If no, problem at work/studying, 8) problem with partner or close friend, 9) cause sexual difficulties, 10) problem caused by treatment. Total score ranged from 0-30,where,0-1=no effect at all on life;2-5=small effect on life; 6-10=moderate effect on life;11-20=very large effect on life;21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease. ITT population consisted of the entire population enrolled and randomised.Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    120
    126
    Units: Percent change
        arithmetic mean (standard deviation)
    -59.5 ± 66.3
    -59.2 ± 70.6
    No statistical analyses for this end point

    Secondary: EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)

    Close Top of page
    End point title
    EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)
    End point description
    EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on subject's quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. An increase in the EQ-5D-5L total score indicates improvement. ITT population consisted of the entire population enrolled and randomised. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12/Last visit or early termination visit
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    125
    129
    Units: Units on a scale
        arithmetic mean (standard deviation)
    83.5 ± 16.2
    83.0 ± 15.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Each EuroQol-5 Dimension-5 Level Questionnaire Questions at Baseline and Week 12 (last visit/early termination)

    Close Top of page
    End point title
    Percentage of Subjects in Each EuroQol-5 Dimension-5 Level Questionnaire Questions at Baseline and Week 12 (last visit/early termination)
    End point description
    EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on subject's quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. An increase in the EQ-5D-5L total score indicates improvement. ITT population consisted of the entire population enrolled and randomised. Here 'n' (number analyzed) signifies number of subject evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12 (last visit/early termination)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    135
    138
    Units: Percentage of Subjects
    number (not applicable)
        Baseline: Mobility (n=135,138)
    80
    84.1
        Baseline: Self-care (n=135,138)
    96.3
    97.8
        Baseline: Usual activities (n=135,138)
    85.9
    89.1
        Baseline: Pain/discomfort (n=135,138)
    55.6
    57.2
        Baseline: Anxiety/depression (n=135,138)
    65.9
    69.6
        Last visit: Mobility (n=125,129)
    80.0
    83.7
        Last visit: Self-care (n=125,129)
    94.4
    96.9
        Last visit: Usual activities (n=125,129)
    89.6
    90.7
        Last visit: Pain/discomfort (n=125,129)
    68.0
    79.1
        Last visit: Anxiety/depression (n=125,129)
    77.6
    82.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit)

    Close Top of page
    End point title
    Percentage of Subjects Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit)
    End point description
    WPAI:GH questionnaire was an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. Currently Employed question was assessed in this outcome measure. ITT population consisted of the entire population enrolled and randomised. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    125
    128
    Units: percentage of subjects
    number (not applicable)
        Yes
    65.9
    65.2
        No
    34.1
    34.8
    No statistical analyses for this end point

    Secondary: Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire at Week 12 (Last Visit/Early Termination Visit)

    Close Top of page
    End point title
    Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire at Week 12 (Last Visit/Early Termination Visit)
    End point description
    WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: missed hours from work because of rosacea?, missed hours from work because of other reason?, number of Working hours. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. ITT population consisted of the entire population enrolled and randomised. Here 'n' (number analyzed) signifies number of subject evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/Early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    80
    82
    Units: hours
    arithmetic mean (standard deviation)
        Missed hours from work because of rosacea
    0.1 ± 0.9
    0.0 ± 0.0
        Missed hours from work because of other reason
    4.2 ± 10.9
    2.9 ± 9.6
        Number of Working hours
    36.3 ± 17.7
    38.2 ± 14.8
    No statistical analyses for this end point

    Secondary: Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit)

    Close Top of page
    End point title
    Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit)
    End point description
    WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: 5)how much rosacea affect productivity at work?; 6) how much rosacea affect daily activity?. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. ITT population consisted of the entire population enrolled and randomized. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/Early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    125
    128
    Units: units on a scale
    arithmetic mean (standard deviation)
        How much rosacea affect productivity at work
    0.6 ± 1.5
    0.5 ± 1.2
        How much rosacea affect daily activity
    0.5 ± 1.3
    0.7 ± 1.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A

    Close Top of page
    End point title
    Percentage of Subjects Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A
    End point description
    Subject’s satisfaction questionnaire was used to specifically collect the subjects feedback on the treatment, the level of satisfaction and future usage. Questionnaire consisted of 4 parts: Part A, B, C and D. where Part A consisted of following 12 questions (Q) about study drugs: 1-Time the study regimen took to work, 2-Improvement of facial lesions, 3-Improvement of facial redness, 4-Improvement of ocular symptoms, 5-Improvement of flushing episodes, 6-How bothered by side effects, 7-Your face looks, 8-You feel, 9-Easy to incorporate in daily routine, 10-Using the study regimen again, 11-Overall satisfaction, 12-Compared to last treatment. Satisfied score of questionnaire meant as subjects responded as Very satisfied (Q -1,2,3,4,5,11), Not bothered at all (Q-6),A lot better (Q- 7,8,12), yes (Q-10), strongly agree (Q-9). ITT population consisted of the entire population enrolled and randomised. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    125
    129
    Units: percentage of subjects
    number (not applicable)
        1.Time the study regimen took to work
    48.0
    45.0
        2.Improvement of facial lesions
    48.0
    46.5
        3.Improvement of facial redness
    45.6
    41.1
        4.Improvement of ocular symptoms
    25.6
    26.4
        5.Improvement of flushing episodes
    41.6
    38.0
        6.How bothered by side effects
    84.0
    76.7
        7.Your face looks
    70.4
    65.9
        8.You feel
    61.6
    55.0
        9.Easy to incorporate in daily routine
    62.4
    58.9
        10.Using the study regimen again
    86.4
    82.9
        11.Overall satisfaction
    54.4
    52.7
        12.Compared to last treatment
    42.4
    41.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B

    Close Top of page
    End point title
    Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B
    End point description
    Part B of Questionnaire consisted of following 10 questions about both provided skin care products cleanser and moisturizer: 1-Easy to incorporate into a daily routine, 2-Recommend to my family or friends, 3-Help my skin look healthier, 4-More confident with rosacea, 5-More confident with skin appearance, 6-Positive difference in the appearance, 7-Keep using both skin care products, 8-Make my skin more hydrated, 9-Improve the texture of my skin, 10-Pleasant to use. ITT population consisted of the entire population enrolled and randomised. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    124
    129
    Units: percentage of subjects
    number (not applicable)
        1.Easy to incorporate into a daily routine
    68.5
    70.5
        2.Recommend to my family or friends
    60.5
    52.7
        3.Help my skin look healthier
    58.1
    50.4
        4.More confident with rosacea
    33.1
    32.6
        5.More confident with skin appearance
    37.9
    36.4
        6.Positive difference in the appearance
    47.6
    44.2
        7.Keep using both skin care products
    52.4
    48.8
        8.Make my skin more hydrated
    42.7
    38.8
        9.Improve the texture of my skin
    35.5
    34.9
        10.Pleasant to use
    54.0
    50.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C

    Close Top of page
    End point title
    Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C
    End point description
    Part C subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product cleanser: 1- Clean healthy skin feeling, 2-Deep cleansing without stripping moisture, 3-Rinsed off easily, 4-Not make my skin feel tight or dry. ITT population consisted of the entire population enrolled and randomised. Here 'N' (subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit or early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    124
    129
    Units: percentage of subjects
    number (not applicable)
        1.Clean healthy skin feeling
    49.2
    46.5
        2.Deep cleansing without stripping moisture
    41.1
    40.3
        3.Rinsed off easily
    54.0
    48.8
        4.Not make my skin feel tight or dry
    59.7
    50.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D

    Close Top of page
    End point title
    Percentage of Subjects Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D
    End point description
    Part D of subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product moisturizer: 1-Skin feel soft and smooth, 2-Improve my skin moisture, 3-Leave my skin hydrated and protected, 4-Provide comforting sensation.
    End point type
    Secondary
    End point timeframe
    Week 12 (Last visit/early termination visit)
    End point values
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Number of subjects analysed
    123
    129
    Units: percentage of subjects
    number (not applicable)
        1.Skin feel soft and smooth
    48.0
    35.7
        2.Improve my skin moisture
    38.2
    34.1
        3.Leave my skin hydrated and protected
    42.3
    38.0
        4.Provide comforting sensation
    43.9
    37.2
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the signing of the informed consent form (ICF) up to week 12
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules
    Reporting group description
    Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.

    Reporting group title
    Ivermectin 1% Cream + Oral Placebo Capsules
    Reporting group description
    Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.

    Serious adverse events
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 138 (0.72%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Hepatobiliary disorders
    Cholezystolithiasis
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Multilevel discopathy in the cervical spine
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% Cream + Oral Placebo Capsules
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 135 (12.59%)
    33 / 138 (23.91%)
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    2 / 135 (1.48%)
    1 / 138 (0.72%)
         occurrences all number
    2
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 135 (2.22%)
    3 / 138 (2.17%)
         occurrences all number
    3
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 135 (0.74%)
    6 / 138 (4.35%)
         occurrences all number
    1
    6
    Nausea
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Rosacea
         subjects affected / exposed
    1 / 135 (0.74%)
    2 / 138 (1.45%)
         occurrences all number
    1
    2
    Skin irritation
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    2 / 135 (1.48%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 135 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    6 / 135 (4.44%)
    10 / 138 (7.25%)
         occurrences all number
    6
    10
    Rhinitis
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 135 (1.48%)
    2 / 138 (1.45%)
         occurrences all number
    2
    2

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA