Trial to compare the efficacy and safety of tretinoin clindamycin phosphate gel to clindamycin phosphate gel alone, tretinoin gel alone, and vehicle in the treatment of acne vulgaris in patients from 12 to less than 18 years of age.
- Conditions
- Treatment of acne vulgarisMedDRA version: 14.1Level: HLTClassification code 10000497Term: AcnesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2010-022918-15-Outside-EU/EEA
- Lead Sponsor
- Dow Pharmaceutical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 1288
•Male or female subjects of any race
•12 years of age or older
•acne vulgaris
•20-50 inflammatory lesions (papules and pustules)
•20-100 non-inflammatory lesions (open and closed comedones)
•= 2 nodules.
Are the trial subjects under 18? yes
Number of subjects for this age range: 795
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 493
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, etc;
•Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy;
•Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the trial, or become pregnant during the study;
•History of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
•Treatment of any type for cancer within the last 6 months;
•History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator’s Brochure, including known sensitivities to any dosage form of clindamycin, lincomycin or tretinoin;
•Recent history or concurrent use of certain topical or systemic medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ---;Timepoint(s) of evaluation of this end point: see above;Main Objective: To compare the efficacy and safety of Clin-RA Gel to Clindamycin phosphate 1.2% Gel alone, Tretinoin 0.025% Gel alone, and Clin-RA Gel vehicle in the treatment of acne vulgaris.;Primary end point(s): Co-primary efficacy variables:<br>1.Percent change from baseline to Week 12 in inflammatory lesion counts;<br>2.Percent change from baseline to Week 12 in non-inflammatory lesion counts;<br>3.Percent change from baseline to Week 12 in total lesion counts;<br>4.Dichotomised Global Severity Score: Percentage of subjects who had the Evaluator’s Gobal Severity Score of clear or almost clear at Week 12.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Efficacy - Modified Dichotomised Global Severity Score: Percentage of subjects who were clear or almost clear at Week 12 or achieved at least 2 grades of improvement in the Evaluator's Global Severity Score from Baseline to Week 12;<br>2.Efficacy - Percentage of subjects with a Baseline Evaluator's Global Severity Score of at least severe (=4 or 5) who achieved at least a 2-grade improvement in the Evaluator's Global Severity Score from Baseline to Week 12;<br>3.Safety - Safety measurements, including cutaneous safety and tolerability evaluations and adverse event (AE) monitoring, were conducted at each visit (Week 2, 4, 8 and 12).<br>;Timepoint(s) of evaluation of this end point: see above