Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Phase 1
Completed
- Conditions
- Acne Vulgaris
- Registration Number
- NCT00361322
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
The concept behind our study was to combine an effect of antibiotic and anti-inflammatory agents for a more efficient acne therapy directed at the factors involved in the pathophysiology of the disease. For this purpose we evaluated a combination of clindamycin phosphate and salicylic acid in a non-irritating carrier.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- mild to moderate acne vulgaris;
- at least 5 lesions on the face;
- a one-month wash-out period was established for any topical or systemic drug use for treatment of acne vulgaris.
Exclusion Criteria
- acne that was primarily truncal, nodular, or due to secondary causes/internal disease;
- pregnancy, breastfeeding, or intention to become pregnant;
- another dermatological disease of the face;
- significant systemic disease;
- any drug/alcohol addiction;
- interacting medication;
- known hypersensitivity to study medications;
- history of chronic disease treated with medications which might affect acne condition and treatment outcome (e.g. corticosteroids, lithium, isoniazid, anti-androgens, phenytoin, phenobarbital) in the preceding month
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Lesions count at the end of study (week 8) Lesions count at the baseline (week 0)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel