Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Anti-Inflammatory Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Salicylates; Salicylic Acid

Criteria

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