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

This study has been completed.

First Received: August 6, 2006 No Changes Posted

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00361322

Purpose

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	Intervention	Phase
Acne Vulgaris	Drug: clindamycin phosphate Drug: salicylic acid	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Topical Clindamycin Salicylic Acid Preparation for the Treatment of Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne Antibiotics

Drug Information available for: Salicylic acid Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	April 2005
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361322

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

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

More Information

No publications provided

Study ID Numbers:	CLSA-HMO-CTIL
Study First Received:	August 6, 2006
Last Updated:	August 6, 2006
ClinicalTrials.gov Identifier:	NCT00361322 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Clindamycin
Facial Dermatoses
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Clindamycin-2-phosphate
Enzyme Inhibitors
Sebaceous Gland Diseases
Acne Vulgaris

Pharmacologic Actions
Keratolytic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Acneiform Eruptions
Antifungal Agents
Therapeutic Uses
Salicylic Acid
Dermatologic Agents

ClinicalTrials.gov processed this record on February 08, 2010