An observer blind, parallel group, randomised multicentre study to compare the safety and efficacy of a new formulation of topical clindamycin phosphate in patients with mild to moderate acne
Completed
- Conditions
- Mild to moderate acne vulgaris.Skin and Connective Tissue DiseasesAcne
- Registration Number
- ISRCTN72179764
- Lead Sponsor
- ProStrakan Pharmaceuticals (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
Consenting patients of either sex, between 12 and 40 years of age, with mild to moderate inflammatory acne with a grade ranging from 2.0 to 7.0 (The Leeds Revised Acne Grading System, 1998).
Exclusion Criteria
1. Patients with significant nodulocystic acne
2. Use of systemic topical antibiotics within 4 weeks prior to the start of treatment
3. Concomitant medication which may interfere with study evaluation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).
- Secondary Outcome Measures
Name Time Method 1. The change in acne grade (The Leeds Revised Acne Grading System, 1998) from the baseline visit to the end of treatment<br>2. The change in number of total comedones, open comedones, closed comedomes, pustules<br>3. Mean change in total lesion count<br>4. Patient?s global assessment<br>5. Investigator?s global assessment