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
Sponsors
Medicis Pharmaceutical Corporation
Dow Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male of female subjects of any race; • 12 years of age or older; • Mild, moderate or severe acne vulgaris. Are the trial subjects under 18? yes Number of subjects for this age range: 242 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical drug or device research study within 30 days of enrollment or participation in a research study concurrent with this study; 2. Any dermatological conditions on the face that could have interfered with clinical evaluations, such as acne conglobata, acne fulminans, secondary acne, etc.; 3. History of regional enteritis, ulcerative colitis or antibiotic-associated colitis; 4. Treatment of any type for cancer within the last 6 months; 5. 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; 6. Use of the following at Screening/Baseline: • topical antibiotics on the facial area (Azelaic Acid, erythromycin); • anti-inflammatories and corticosteroids on the face; • topical retinoids, including retinol, on the face.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the long-term safety of the new combination therapy as a monotherapy or with other concomitant acne medications for a six month period or one year period.;Secondary Objective: The secondary objective of the study is to assess patterns of use of the new combination formulation by following the circumstances for treatment discontinuation and re-initiation of therapy.;Primary end point(s): 1. Safety - Overall experience of adverse events (AEs) and analysis of AEs; 2. Safety - Cutaneous safety evaluations (erythema and scaling) were performed at Baseline and Months 1 through 12; 3. Safety - Tolerability evaluations (burning, itching and stinging) were performed at Baseline and Months 1 through 12; 4. Efficacy - Evaluator's Global Severity Score was measured at Baseline and Months 1 through 12; 5. Efficacy - Time to initial clearing; 6. Efficacy - Time to first elapse.;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - Rationale for Continued Therapy;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