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    Summary
    EudraCT Number:2015-004909-16
    Sponsor's Protocol Code Number:STF114543
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-08-03
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004909-16
    A.3Full title of the trial
    A Multicentre, Randomized, Assessor-blind, Comparator-Controlled, Parallel-Group Clinical Trial to Establish the Efficacy and Safety of Duac™(1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide) Once Daily Gel Compared with Clindamycin Phosphate gel (1% clindamycin as clindamycin phosphate) twice daily 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
    Comparison of the Efficacy and Safety of Duac™ Once Daily Gel with Clindamycin Phosphate gel twice daily in Treatment of Acne.
    A.4.1Sponsor's protocol code numberSTF114543
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01915732
    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 SponsorGlaxoSmithKline R&D Ltd
    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 supportglaxosmithkline
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408007839733
    D. IMP Identification
    D.IMP: 1
    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 Duac
    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 nameDuac
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclindamycin
    D.3.9.3Other descriptive nameCLINDAMYCIN PHOSPHATE
    D.3.9.4EV Substance CodeSUB01344MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 INNbenzoyl peroxide
    D.3.9.3Other descriptive nameBENZOYL PEROXIDE
    D.3.9.4EV Substance CodeSUB13020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration 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) 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
    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
    To evaluate the efficacy of Duac Once Daily Gel compared with clindamycin phosphate gel in the topical treatment of mild to moderate acne vulgaris.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of Duac Once Daily Gel compared with clindamycin phosphate gel in the topical treatment of mild to moderate acne vulgaris.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects between 12 and 45 years of age, inclusive age were calculated by date of birth, from 0 at birth.
    2. Subjects who had:
    i. A minimum of 17 but not more than 60 facial inflammatory lesions (papules plus pustules), and no more than 1 facial nodular lesion, with NO cystic lesions.
    and
    ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
    3. Subjects who had an ISGA score of 2 or 3 at Baseline.
    4. Subjects 18 years of age or older had to provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent had to provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
    5. Subjects who were willing and able to complete the study, to understand and comply with the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
    6. Subjects who were in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
    7. Female subjects of childbearing potential had to have a negative pregnancy test at Baseline. Sexually active females of childbearing potential participating in the study had to use a medically acceptable method of contraception for at least 6 consecutive months prior to start of study treatment, and had to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential was defined as one who was biologically capable of becoming pregnant; including perimenopausal women who were less than 2 years from their last menses. Medically acceptable contraceptive methods include the following:
    • Hormonal contraception, including oral, injectable, or implantable methods started at least 6 months prior to screening.
    • Reliable barrier methods include condoms and diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they were used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal ligation or partner’s vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide were acceptable.
    Females who were not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
    Subjects who had been treated with estrogens, androgens, or anti-androgenic agents used for prevention of pregnancy (and not for control of acne) for at least 6 consecutive months prior to the first dose of investigational product might enrol as long as they did not expect to change dose, drug, or discontinue use during the study.
    E.4Principal exclusion criteria
    1. Female subjects who were pregnant, trying to become pregnant, or who were lactating.
    2. Subjects who had cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
    3. Subjects who had 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.
    4. Subjects who had facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
    5. Subjects who had a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
    6. Subjects who had used a prohibited medication, or undergone a prohibited procedure or treatment within the required washout period.
    7. Subjects who had a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, or excipients of the investigational product.
    8. Subjects who were employees of a clinical research organization involved in the study, Stiefel, or GSK or who are an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee, the investigator, or his/her study staff.
    9. Subjects who had a member of the same household in this study at the same time.
    10. Subjects who had used traditional remedies known to affect acne vulgaris within the last 4 weeks.
    11. Subjects who had had any major illness within 30 days before study enrolment.
    12. Subjects who had any other condition that in the judgement of the investigator would put the subject at unacceptable risk for participation in the study.
    13. Subjects who had participated in any clinical trials or taken any investigate drugs within 4 weeks before study enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    1) Absolute change in inflammatory and noninflammatory (total) lesion counts from Baseline to Week 12 (LOCF)
    2) Proportion of an improvement in ISGA score of ≥2 grades from Baseline at Week 12 (LOCF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline (week 0) to Week 12
    E.5.2Secondary end point(s)
    • Absolute change in inflammatory lesion counts from Baseline to Week 12 (LOCF)
    • Absolute change in noninflammatory lesion counts from Baseline to Week 12 (LOCF)
    • Percent change in total lesion counts from Baseline to Week 12 (LOCF)
    • Percent change in inflammatory lesion counts from Baseline to Week 12 (LOCF)
    • Percent change in noninflammatory lesion counts from Baseline to Week 12 (LOCF)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline (week 0), week 1, 2, 4 and 8.
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    E.8.7Trial has a data monitoring committee Yes
    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
    Week 12
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    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: 56
    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: 56
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 960
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1020
    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)
    Post-study treatment with investigational product will not be provided
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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