Trial to assess the long-term safety of tretinoin clindamycin phosphate gel in patients from 12 to less than 18 years of age with acne vulgaris.
- 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
- EUCTR2010-022912-37-Outside-EU/EEA
- Lead Sponsor
- Medicis Pharmaceutical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 442
•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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br>2.Safety - Cutaneous safety evaluations (erythema and scaling) were performed at Baseline and Months 1 through 12;<br>3.Safety - Tolerability evaluations (burning, itching and stinging) were performed at Baseline and Months 1 through 12;<br>4.Efficacy - Evaluator's Global Severity Score was measured at Baseline and Months 1 through 12;<br>5.Efficacy - Time to initial clearing;<br>6.Efficacy - Time to first elapse.;Timepoint(s) of evaluation of this end point: see above
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy - Rationale for Continued Therapy;Timepoint(s) of evaluation of this end point: see above