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

NCT ID: NCT00361322

Last Updated: 2006-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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clindamycin phosphate

Intervention Type DRUG

salicylic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Vera Leibovici, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Arie Ingber, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Elka Touitou, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

The Hebrew University of Jerusalem, Jerusalem, Israel

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CLSA-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id