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    Summary
    EudraCT Number:2015-001448-13
    Sponsor's Protocol Code Number:RD.03.SPR.105041
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-001448-13
    A.3Full title of the trial
    Benzaknen® 5% Gel in combination with Dermotivin® Soft Liquid cleanser and non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the treatment of mild-to-moderate acne vulgaris
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benzaknen® 5% Gel in combination with Dermotivin® Soft Liquid cleanser and non-comedogenic Cetaphil® Dermacontrol Moisturizer SPF30 in the treatment of mild-to-moderate acne vulgaris
    A.4.1Sponsor's protocol code numberRD.03.SPR.105041
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalderma R&D
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGalderma R&D
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma R&D
    B.5.2Functional name of contact pointStéphanie Leclerc
    B.5.3 Address:
    B.5.3.1Street AddressLes Templiers 2400, Route des Colles - BP 87
    B.5.3.2Town/ citySophia Antipolis Cedex
    B.5.3.3Post code06902
    B.5.3.4CountryFrance
    B.5.4Telephone number+33492386706
    B.5.5Fax number+33493957164
    B.5.6E-mailStephanie.Leclerc@galderma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Benzaknen® 5% Gel
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBenzaknen® 5% Gel
    D.3.2Product code 1858.00.00
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenzoylperoxid
    D.3.9.3Other descriptive nameBENZOYL PEROXIDE
    D.3.9.4EV Substance CodeSUB13020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acne vulgaris (AV)
    E.1.1.1Medical condition in easily understood language
    Acne
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with Dermotivin® Soft Liquid cleanser and Cetaphil® Dermacontrol Moisturizer SPF30 after 12 weeks of treatment. The safety and efficacy of this treatment regimen will also be evaluated.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for the study, subjects must fulfil all of the following criteria:
    1. Male or female subject of any ethnic background of 12 years or older,

    2. Subject with mild or moderate facial acne vulgaris (IGA 2 or 3),
    Investigator’s Global Assessment:
    0 - Clear - Residual hyperpigmentation and erythema may be present
    1 - Almost Clear - A few scattered comedones and a few small papules
    2 - Mild - Some comedones and some papules and pustules. No nodules present
    3 - Moderate - Many comedones, papules and pustules.
    4 - Severe - Covered with comedones, numerous papules and pustules and a few nodules may be present

    3. Subject with any skin phototype (according to T.B. Fitzpatrick skin phototype definitions*)

    4. Female of childbearing potential with a negative Urine Pregnancy Test (UPT) at Baseline must practice a highly effective method of contraception during the study: oral /systemic (injectable, patch, etc.) contraception (must have been on stable dose for 3 months prior to study entry), bilateral tubal ligation, hormonal intrauterine device (IUD) inserted at least 1 month prior to Baseline, strict abstinence, or partner had a vasectomy,

    5. Female of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 1 years), hysterectomy, or bilateral oophorectomy are not required to have a UPT at Baseline,

    6. Subject (or the parents/legal representative for subjects age under 18) willing and capable of complying with the extent and degree required by the protocol,

    7. Subject (or the parents/legal representative for subjects age under 18) having read and signed the approved Informed Consent Form prior to any participation in the study. Subjects under the age of 18 must sign an assent form to participate in the study and they must have one parents or guardian read and sign the Informed Consent Form prior to any study related procedures,

    8. Subject must be willing to be photographed. Subject (and parents/guardian if subject is under 18 years of age) must be willing to sign a Photography Release Consent Form.
    E.4Principal exclusion criteria
    Any subject who meets one or more of the following criteria will not be eligible for the study:
    1. Subject with severe acne (IGA>3) with nodules, cysts, scars or extra-facial lesions,

    2. Female subject who is pregnant, lactating or planning a pregnancy during the study,

    3. Female Taking Diane-35,

    4. Subject with an acute or chronic disease that could interfere with study results,

    5. Subject susceptible to take a corticosteroid treatment during the study except inhaled or topic when needed to treat a condition outside the face,

    6. Subject with a dermatologic condition on the face other than acne that might put the subject at risk or interfere with study evaluations,

    7. Subject using another facial cosmetic product than the one received for this study

    8. Subject with acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.),

    9. Subject with a wash-out period for topical treatment or procedures on the face less than:
    Topical treatments: Corticosteroids, antibiotics, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments 2 weeks
    Medical Procedures: laser resurfacing, deep chemical peel, plastic surgery 12 months
    Cosmetic procedure (e.g., facials, superficial peels, blue light, comedone extraction, microdermabrasion) on facial areas 4 weeks

    10. Subject with a wash-out period for systemic treatment less than (see table below):
    Corticosteroids, tetracyclines, other antibiotics 4 weeks
    Oral isotretinoin 6 months
    Ciproterone acetate 2 months
    Spironolactone 2 months

    11. Subject with active or chronic skin allergies,

    12. Subject with known or suspected allergy to the investigational product (see package insert),

    13. Subject with damaged facial skin (e.g., sunburn, tattoo, or scar),

    14. Subject who foresees intensive UV exposure during the study (mountain sports, sailing, sunbathing, etc),

    15. Subject with a history of photosensitivity,

    16. Subject who is at risk in terms of precautions, warnings, and contraindications (see package insert),

    17. Subject with a beard or other facial hair that might interfere with study assessments,

    18. Subject with a history of major medical or psychiatric condition or surgical interventions that, in the opinion of the investigator, might put the subject at risk,

    19. Subject under guardianship, hospitalized subject in a public or private institution for a reason other than the research, and subject deprived of his/her freedom,

    20. Subject who has participated in another investigational drug or device research study within 30 days prior to enrolment.

    21. Subject who is employee of the study site or of the sponsors company.
    E.5 End points
    E.5.1Primary end point(s)
    Patients satisfaction, evaluated by patient satisfaction questionnaire
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12/Early termination
    E.5.2Secondary end point(s)
    Percent change from Baseline in total lesion count (sum of non inflammatory and
    inflammatory lesions)
    • Percent change from Baseline in inflammatory lesion count
    • Percent change from Baseline in non-inflammatory lesion count
    • Global Assessment of Improvement from Baseline: % of subjects across scores
    Safety variables
    • Incidence of Adverse Events,
    • Local tolerability worst-score post Baseline: % of subjects across scores,
    Other
    •Percent change from Baseline in number of orange fluorescent pixels with UV fluorescence
    photography.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each study visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patients satisfaction with acne treatment regimen.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open-label single center, prospective study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 15
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-15
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