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    Summary
    EudraCT Number:2014-001755-23
    Sponsor's Protocol Code Number:RD.06.SPR.18250
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-09
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-001755-23
    A.3Full title of the trial
    A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50μg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 50μg/g CREAM IN SUBJECTS WITH ACNE VULGARIS
    A.3.2Name or abbreviated title of the trial where available
    CD5789 Long Term Study (LTS) on acne vulgaris
    A.4.1Sponsor's protocol code numberRD.06.SPR.18250
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/231/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalderma R&D SNC
    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 SNC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma R&D SNC
    B.5.2Functional name of contact pointCTA Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressLes Templiers, 2400 Route des Colles
    B.5.3.2Town/ cityBiot
    B.5.3.3Post code06410
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)493-95-70-85
    B.5.5Fax number+33(0)492-95-21-31
    B.5.6E-mailcta.coordinator@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 No
    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.3.2Product code CD5789
    D.3.4Pharmaceutical form Cream
    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 INNTrifarotene
    D.3.9.1CAS number 895542-09-3
    D.3.9.2Current sponsor codeCD5789
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 μg/g
    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
    E.1.1.1Medical condition in easily understood language
    Acne Vulgaris
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne vulgaris
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and efficacy of CD5789 50μg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris.
    E.2.2Secondary objectives of the trial
    Efficacy will be evaluated as a secondary objective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, 9 years of age and older at Screening visit.

    - The Subject has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.

    - The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.

    - The subject has truncal acne severity grade of PGA 3 (moderate) at Screening and Baseline visits on the shoulders, anterior chest and upper back reachable to self-application of study drug by the subject (this inclusion criterion is optional for children between 9 and 11 years old).

    - The subject has a minimum of 20 inflammatory lesions and 20 noninflammatory lesions at Screening and Baseline visits on the shoulders, upper back and anterior chest (this inclusion criterion is optional for children between 9 and 11 years old).
    E.4Principal exclusion criteria
    - The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).

    - The Subject has more than 1 nodule on the face at Screening and at Baseline visits.

    - The Subject has more than 1 nodule on the trunk at Screening and at Baseline visits.

    - The Subject has any acne cyst on the face at Screening and at Baseline visits.

    - The Subject has any acne cyst on the trunk at Screening and at Baseline visits.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    1- assessment of local tolerability on treated areas and adverse events,
    2- vital signs and physical eamination,
    3- and laboratory tests
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- at each visit
    2- at Screening, baseline, WE12, W26 and W52
    3- at Screening, baseline, W26 and W52
    E.5.2Secondary end point(s)
    Efficacy :
    - success rate of IGA,
    - success rate of PGA,
    - grade change from baseline of PGA,
    - grade change from baseline of IGA,
    - subject's assessement
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each time point
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Germany
    Hungary
    United States
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 110
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 450
    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)
    At the end of the study, the investigator will discuss with the subject further available therapies and/or treatment to manage his/her acne
    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 Decision2014-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-23
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