Efficacy and Safety of a Preparation Containing an Antibiotic and Anti-Inflammatory Agent in Acne Vulgaris
Overview
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.
Full Title of Study: “Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
Interventions
- Drug: clindamycin phosphate
- Drug: salicylic acid
Clinical Trial Outcome Measures
Primary Measures
- Lesions count at the baseline (week 0)
- Lesions count at the end of study (week 8)
Participating in This Clinical Trial
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: All
Minimum Age: 18 Years
Maximum Age: 45 Years
Investigator Details
- Lead Sponsor
- Hadassah Medical Organization
- Overall Official(s)
- Vera Leibovici, MD, Principal Investigator, Hadassah Medical Organization
- Arie Ingber, MD, Prof, Principal Investigator, Hadassah Medical Organization
- Elka Touitou, PhD, Prof, Principal Investigator, The Hebrew University of Jerusalem, Jerusalem, Israel
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