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    Summary
    EudraCT Number:2008-002359-26
    Sponsor's Protocol Code Number:S194-401
    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:2008-06-26
    Trial 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 number2008-002359-26
    A.3Full title of the trial
    A multi-center, randomized, evaluator-blind, parallel group study evaluation of the efficacy, safety, and tolerability of DUAC® Akne Gel and Epiduo® Gel in the topical treatment of facial acne vulgaris

    A.4.1Sponsor's protocol code numberS194-401
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorStiefel Laboratories
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DUAC® Akne Gel
    D.2.1.1.2Name of the Marketing Authorisation holderStiefel Laboratorium GmbH
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNclindamycin dihydrogenphosphate
    D.3.9.1CAS number 24729-96-2
    D.3.9.2Current sponsor codeS194
    D.3.9.3Other descriptive nameclindamycin phosphate
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdibenzoyl peroxide
    D.3.9.1CAS number 94-36-0
    D.3.9.2Current sponsor codeS194
    D.3.9.3Other descriptive namebenzoyl peroxide, hydrous
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Epiduo 0.1%/2.5% Gel
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Laboratorium GmbH
    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.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNadapalene
    D.3.9.1CAS number 106685-40-9
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdibenzoyl peroxide
    D.3.9.1CAS number 94-36-0
    D.3.9.2Current sponsor codeS194
    D.3.9.3Other descriptive namebenzoyl peroxide, hydrous
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000519
    E.1.2Term Acne vulgaris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Duac Akne Gel compared with Epiduo Gel in the treatment of facial acne vulgaris by assessing the percent change in inflammatory lesion count (papules and pustules, including nasal lesions) from baseline to week 12.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of Duac Akne Gel compared with Epiduo Gel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are males or females 12 to 45 years of age, inclusive, in good general health.
    2. Subjects who are capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed. NOTE - Subjects under 18 years of age must provide assent and have the written, informed consent of the parent(s) or legal guardian responsible for their custody.
    3. Subjects who are willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
    4. Subjects who have: A minimum of 25 to a maximum of 80 inflammatory facial lesions (papules and pustules), including the nose, and no facial nodular cystic lesions. AND A minimum of 12 to a maximum of 100 non-inflammatory facial lesions (open and closed comedones), excluding the nasal area.
    5. Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, double-barrier methods, or condom plus spermatocide) for more than 12 consecutive weeks prior to start of study treatment and are allowed to enroll only if they do not expect to change dose, drug, or discontinue using contraception during the study.
    6. Subjects who have been treated with estrogens, androgens, or anti?androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
    7. Subjects who have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
    E.4Principal exclusion criteria
    1. Female subjects who are pregnant, trying to become pregnant, or who are lactating.
    2. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
    3. Subjects who have facial hair that may obscure the accurate assessment of acne grade.
    4. Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
    5. Subjects who have used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
    6. Subjects who have used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra?articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
    7. Subjects who have used systemic retinoids within the past 6 months.
    8. Subjects who are using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
    9. Subjects who are using neuromuscular blocking agents. Clindamycin
    has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
    10. Subjects who have used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
    11. Subjects who have used any investigational therapy within 4 weeks of study day 1.
    12. Subjects who are using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids.
    13. Subjects who are using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12; haloperidol; halogens such as iodide and bromide; lithium; hydantoin; and phenobarbital) as these may impact efficacy assessments.
    14. Subjects who have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
    15. Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
    16. Subjects who are employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee, the investigator, or his/her study staff.
    17. Subjects who have a member of the same household in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of percent change in inflammatory lesion count from baseline to week 12 will be analyzed at an alpha level of 0.05 using analysis of covariance (ANCOVA) with treatment, center, and baseline lesion count in the model. The assumption of normality will be verified using the Shapiro-Wilk test with a threshold value of 0.1. If the assumption is not met, the data will be ln-transformed for the primary analysis. If the In-transformed data are also not normal, the data will instead be rank?transformed. Missing values will be imputed using the Last Observation Carried Forward (LOCF) method.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned19
    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 Information not present in EudraCT
    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
    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.1.1.1In 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.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents (12-17 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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 Decision2008-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-28
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