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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