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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00361322

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: clindamycin phosphate Drug: salicylic acid	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Study Start Date :

Apr 1, 2005

Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

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