Treatment of acne vulgaris MedDRA version: 14.1 Level: HLT Classification code 10000497 Term: Acnes System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Clin-RA Gel
Pharmaceutical Form: Gel
INN or Proposed INN: CLINDAMYCIN PHOSPHATE
CAS Number: 24729-96-2
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concent
Sponsors
Dow Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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: 800 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 452 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: none;Primary end point(s): Co-primary efficacy variables: 1. Percent change from baseline to Week 12 in inflammatory lesion counts; 2. Percent change from baseline to Week 12 in non-inflammatory lesion counts; 3. Percent change from baseline to Week 12 in total lesion counts; 4. Dichotomised Evaluator’s Global Severity Score (EGSS): Percentage of subjects who had the Evaluator’s Global Severity Score of clear or almost clear at Week 12. ;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; 2. Efficacy - Percentage of subjects with a Baseline Evaluator's Global Severity Score of severe (=4) who achieved at least a 2-grade improvement in the Evaluator's Global Severity Score from Baseline to Week 12; 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). ;Timepoint(s) of evaluation of this end point: see above | — |
Countries
United States
Contacts
Public ContactDepartment Clinical Development
MEDA Pharma GmbH & Co. KG
Outcome results
None listed