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    Clinical Trial Results:
    THE EFFECT OF AZELAIC ACID ON SYMPTOMS OF ACNE IN FEMALE PATIENTS AGE 20-45 WITH MILD TO MODERATE PAPULOPUSTULAR ACNE (ACNE TARDA)

    Summary
    EudraCT number
    		 2013-000416-24
    Trial protocol
    		 DE  
    Global end of trial date
    04 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2021
    First version publication date
    12 May 2021
    Other versions
    Summary report(s)
    		 Acne-A-05 final report

    Trial information

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    Trial identification
    Sponsor protocol code
    CRC-ACNE-A-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dr. Kathrin Hillmann, Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and, 0049 30450518499, kathrin.hillmann@charite.de
    Scientific contact
    Dr. Kathrin Hillmann, Charité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and, 0049 30450518499, kathrin.hillmann@charite.de
    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
    10 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this prospective study was to evaluate, whether the treatment with Skinoren® 15% gel leads to a measurable softer and smoother skin besides the improvement of acne symptoms.
    Protection of trial subjects
    Azelaic acid is licensed since 2003 for the treatment of acne vulgaris in gel formulation. It leads to a decrease of inflammatory and non-inflammatory acne lesions in patients with acne vulgaris as well as acne tarda, All patients receive a licensed anti acne therapy. Application of the product strictly follows the specifications outlined in the “product characteristics. The product is applied on the facial skin areas affected by acne. In case of severe deterioration or in case of non-response within one month other therapeutic strategies are considered. In case of treatment success Skinoren 15% treatment can be continued. Azelaic acid is generally well tolerated, whereas at the beginning of local application irritant reactions like pruritus, burning or stinging frequently occur. During therapy appearances of such possible reactions are expected to diminish. These and other possible adverse reactions of azelaic acid like rash, dryness, erythema and pigmentary abnormality will be examined and evaluated and appropriate actions taken during the study. Patients with known allergic reactions to one or more ingredients of the product are excluded. During the study the patients and their skin are closely monitored. If there is a non-response to treatment or an increase in disease severity, patients are offered alternative therapies. Acna tarda is a chronic condition, thus study participants take advantage of a continuous care. Taking into account the minimal risks and the fact that azelaic acid is a licensed and an effective pharmaceutical for acne patients, the performance of the trial can be considered ethically sound since the expected benefits of the preparations appear greater at present than the risks for the patients. Therefore we consider a positive benefit-to-risk ratio.
    Background therapy
    		 No background therapy
    Evidence for comparator
    		 There was no comparator used
    Actual start date of recruitment
    09 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    53
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Monocenter trial. Screening period was from 9 August 2013 to 20 March 2014.

    Pre-assignment
    Screening details
    		 61 patients were screened. 8 were screening failures. 53 were assigned to treatment.

    Pre-assignment period milestones
    Number of subjects started
    		 61 [1]
    Number of subjects completed
    		 53

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 multiple reasons: 8
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: For reasons of comprehension of the forms, it was not possible for us to enter the number of subjects who had dropped out in the meantime.
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baseline arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azalaic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Azelaic acid 15% twice daily

    Number of subjects in period 1
    		Baseline arm
    Started
    53
    Completed
    53
    Period 2
    Period 2 title
    Visit 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Visit 2 arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azalaic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Azelaic acid 15% twice daily

    Number of subjects in period 2 [2]
    		Visit 2 arm
    Started
    47
    Completed
    47
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: For reasons of comprehension of the forms, it was not possible for us to enter the number of subjects who had dropped out in the meantime.
    Period 3
    Period 3 title
    Visit 3
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Visit 3 arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azalaic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Azelaic acid 15% twice daily

    Number of subjects in period 3 [3]
    		Visit 3 arm
    Started
    45
    Completed
    45
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: For reasons of comprehension of the forms, it was not possible for us to enter the number of subjects who had dropped out in the meantime.
    Period 4
    Period 4 title
    Visit 4
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Visit 4 arm
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azalaic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Azelaic acid 15% twice daily

    Number of subjects in period 4 [4]
    		Visit 4 arm
    Started
    39
    Completed
    39
    Notes
    [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: For reasons of comprehension of the forms, it was not possible for us to enter the number of subjects who had dropped out in the meantime.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 53 53
    Age categorical
    female patients between 20 and 45 years with mild to moderate acne papulopustulosa were included
    Units: Subjects
        Adults (18-64 years)
    		 53 53
    Gender categorical
    Units: Subjects
        Female
    		 53 53
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Baseline arm
    Reporting group description
    		 -
    Reporting group title
    Visit 2 arm
    Reporting group description
    		 -
    Reporting group title
    Visit 3 arm
    Reporting group description
    		 -
    Reporting group title
    Visit 4 arm
    Reporting group description
    		 -

    Primary: Skin Smoothness (SE SM) forehead

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    End point title
    		 Skin Smoothness (SE SM) forehead [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Visit 2, Visit 3, Visit 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The requested data regarding the statistical analysis cannot be answered
    End point values
    		 Baseline arm Visit 2 arm Visit 3 arm Visit 4 arm
    Number of subjects analysed
    53
    47
    45
    39
    Units: eta2
        arithmetic mean (standard deviation)
    55.0 ± 20.1
    42.09 ± 11.26
    43.16 ± 11.0
    49.36 ± 16.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the whole trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary used
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The adverse events are listed individually in the attached study report.

    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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