Official Title: “Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: clindamycin phosphate
• Drug: salicylic acid

Primary Measures

• Lesions count at the baseline (week 0)
• Lesions count at the end of study (week 8)

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Lead Sponsor: Hadassah Medical Organization

Overall Clinical Trial Officials and Contacts

Vera Leibovici, MD Principal Investigator Hadassah Medical Organization, Jerusalem, Israel  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361322

Study ID Number: CLSA-HMO-CTIL

ClinicalTrials.gov Identifier: NCT00361322

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration