Trial to compare the efficacy and safety of tretinoin clindamycin phosphate gel to clindamycin phosphate gel alone in the treatment of acne vulgaris in patients from 12 to less than 18 years of age.

• Conditions: Treatment of Acne vulgaris; MedDRA version: 14.1Level: HLTClassification code 10000497Term: AcnesSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2010-022919-20-Outside-EU/EEA
• Lead Sponsor: Dow Pharmaceutical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 2010

Inclusion Criteria

•Male or female subjects of any race;
•12 years of age or older;
•acne vulgaris;
•20 to 50 inflammatory lesions (papules and pustules);
•20 to 100 noninflammatory lesions (open and closed comedones);
•no more than 2 nodules;
•Evaluator’s Global Severity Score (EGSS) of moderate (=3) or severe (=4).

Are the trial subjects under 18? yes
Number of subjects for this age range: 1320
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 689
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•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
Main Objective: To compare the efficacy and safety of Clin-RA Gel to Clindamycin phosphate 1.2% Gel alone in the treatment of acne vulgaris.;Secondary Objective: ---;Timepoint(s) of evaluation of this end point: see above;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 noninflammatory lesion counts;<br>3.Percent change from Baseline to Week 12 in total lesion counts;<br>4.Dichotomised Evaluator's 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 (EGSS) from Baseline to Week 12.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Efficacy - Percentage of subjects with a Baseline Evaluator's Global Severity Score of severe (=4) or worse who were clear or almost clear at Week 12 or achieved at least a 2-grade improvement in the Evaluator's Global Severity Score from Baseline to Week 12;<br>2.Efficacy - Percentage of subjects who achieved at least a 2-grade improvement from Baseline to Week 12 in the Evaluator's Global Severity Score;<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