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

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: clindamycin phosphate; Drug: salicylic acid

• Study Type: Interventional
• Enrollment: 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Vera Leibovici, MD, Hadassah Medical Organization; Principal Investigator: Arie Ingber, MD, Prof, Hadassah Medical Organization; Principal Investigator: Elka Touitou, PhD, Prof, The Hebrew University of Jerusalem, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Study Completion: January 1, 2006

Study Registration Dates

• First Submitted: August 6, 2006
• First Submitted That Met QC Criteria: August 6, 2006
• First Posted (Estimate): August 8, 2006

Study Record Updates

• Last Update Posted (Estimate): August 8, 2006
• Last Update Submitted That Met QC Criteria: August 6, 2006
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antifungal Agents; Keratolytic Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Salicylic Acid; Salicylates
• Other Study ID Numbers: CLSA-HMO-CTIL