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    Clinical Trial Results:
    A randomized, partially blinded, parallel study to evaluate the effects of nacystelyn in combination with isotretinoin in the treatment of recalcitrant acne vulgaris.

    Summary
    EudraCT number
    		 2020-005270-10
    Trial protocol
    		 BG  
    Global end of trial date
    01 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2023
    First version publication date
    16 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NALISO-II-20-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratoires SMB S.A.
    Sponsor organisation address
    26-28, rue de la Pastorale, Brussels, Belgium, 1080
    Public contact
    Clinical Department, LABORATOIRES SMB S.A., ++32 2 411 48 28, dptclinique@smb.be
    Scientific contact
    Clinical Department, LABORATOIRES SMB S.A., ++32 2 411 48 28, dptclinique@smb.be
    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
    07 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of the nacystelyn in combination with isotretinoin of different concentrations in patients with severe recalcitrant acne vulgaris
    Protection of trial subjects
    The study treatment (isotretinoin) was already on the European market and then were well known by the most of participating patients and investigators. Contraceptive measures and pregnancy tests were mandatory for all women of childbearing potential included in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2021
    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
    Bulgaria: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    35
    Adults (18-64 years)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in five sites in Bulgaria. The recruitment was adequate to meet the target of 90 patients. After the screening visit, the patients were randomized in one of the three groups of treatments. The study extended over 20 weeks of treatment followed by a final visit 4 weeks after the last administration of study treatment.

    Pre-assignment
    Screening details
    		 Screening details: - Obtain signed ICF & assent for adolescents -Obtain demo data - Perform a medical history & physical examination -Take vital signs -Review prior/concomitant medications -Perform laboratory evaluation & pregnancy test -Review inclusion/exclusion criteria -Schedule the randomization visit

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo
    Arm description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn Placebo (2 sachets of placebo) once daily with a glass of water.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Isotretinoin (EPURIS) + Nacystelyn Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Isotretinoin 0.5 mg/kg/day - oral and Nacystelyn Placebo - oral

    Arm title
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg
    Arm description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Isotretinoin (EPURIS) + Nacystelyn 2400 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Isotretinoin 0.5 mg/kg/day - oral and Nacystelyn 2400 mg - oral

    Arm title
    		 Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Arm description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.25 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Isotretinoin (EPURIS) + Nacystelyn 2400 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Isotretinoin 0.25 mg/kg/day - oral and Nacystelyn 2400 mg - oral

    Number of subjects in period 1 [1]
    		Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Started
    28
    29
    30
    Completed
    27
    29
    28
    Not completed
    1
    0
    2
         Consent withdrawn by subject
    1
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Yes, indeed, the number of subjects reported in the baseline period is less than initially foreseen. Three patients were excluded from the analysis set because they did not take any study drug unit (one patient was erroneously randomized and directly withdrawn from the study; and two patients decided to withdraw their consent few hours after signature).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn Placebo (2 sachets of placebo) once daily with a glass of water.

    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.

    Reporting group title
    Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.25 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.

    Reporting group values
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg Total
    Number of subjects
    		 28 29 30 87
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 13 11 10 34
        Adults (18-64 years)
    		 15 18 20 53
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 21.7 ± 8.1 22.1 ± 8.8 21.8 ± 9.1 -
    Gender categorical
    Units: Subjects
        Female
    		 17 16 17 50
        Male
    		 11 13 13 37

    End points

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    End points reporting groups
    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn Placebo (2 sachets of placebo) once daily with a glass of water.

    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.5 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.

    Reporting group title
    Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin administered orally with food once a day as 10 mg or 20 mg capsules at a stable dose of approximately 0.25 mg/kg/day + Nacystelyn 2400 mg (2 sachets of 1200 mg) once daily with a glass of water.

    Primary: Relative change from baseline in the total number of nodules (facial and truncal) at week 20.

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    End point title
    		 Relative change from baseline in the total number of nodules (facial and truncal) at week 20.
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and week 20
    End point values
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Number of subjects analysed
    27
    28
    30
    Units: percentage
        arithmetic mean (standard deviation)
    97.7 ± 6.4
    93.0 ± 14.7
    93.0 ± 11.3
    Statistical analysis title
    		 Mixed model
    Comparison groups
    Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg v Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.67
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -8.8
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.46

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AEs were recorded during the entire study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo
    Reporting group description
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo once a day

    Reporting group title
    Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg once a day

    Reporting group title
    Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Reporting group description
    		 Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg once a day

    Serious adverse events
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Broken arm (Fractura RLT Dextra)
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Isotretinoin 0.5 mg/kg/day + Nacystelyn Placebo Isotretinoin 0.5 mg/kg/day + Nacystelyn 2400 mg Isotretinoin 0.25 mg/kg/day + Nacystelyn 2400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 28 (75.00%)
    25 / 29 (86.21%)
    22 / 30 (73.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 29 (13.79%)
    7 / 30 (23.33%)
         occurrences all number
    1
    14
    15
    Gastrointestinal disorders
    Chapped lips
         subjects affected / exposed
    19 / 28 (67.86%)
    19 / 29 (65.52%)
    16 / 30 (53.33%)
         occurrences all number
    25
    21
    16
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 29 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 29 (6.90%)
    3 / 30 (10.00%)
         occurrences all number
    0
    2
    5
    Dry skin
         subjects affected / exposed
    16 / 28 (57.14%)
    12 / 29 (41.38%)
    9 / 30 (30.00%)
         occurrences all number
    17
    15
    10
    Rash
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    0
    1
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
         occurrences all number
    3
    1
    2
    COVID-19
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    2

    More information

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    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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