Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

NCT ID: NCT00211497

Last Updated: 2005-09-21

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

PHASE2

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2003-09-30

Brief Summary

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This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.

Detailed Description

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Conditions

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Acne Vulgaris Acne Propionibacterium Acnes

Keywords

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acne vulgaris acne Propionibacterium acnes topical inflammatory non-inflammatory lesion counts lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MBI 226 Acne Solutions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females 12 years and older
* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria

* Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
* Active facial cysts or any nodulocystic lesions
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioWest Therapeutics Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jim Pankovich

Role: STUDY_DIRECTOR

BioWest Therapeutics Inc

Other Identifiers

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A99005

Identifier Type: -

Identifier Source: org_study_id