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

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: clindamycin phosphate (Drug); salicylic acid (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Vera Leibovici, MD, Principal Investigator, Affiliation: Hadassah Medical Organization
Arie Ingber, MD, Prof, Principal Investigator, Affiliation: Hadassah Medical Organization
Elka Touitou, PhD, Prof, Principal Investigator, Affiliation: The Hebrew University of Jerusalem, Jerusalem, Israel

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.

Clinical Details

Official title: Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Lesions count at the baseline (week 0)

Lesions count at the end of study (week 8)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information

Starting date: April 2005
Last updated: August 6, 2006

Page last updated: August 20, 2015

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