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Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

Primary Purpose

Acne Vulgaris, Acne, Propionibacterium Acnes

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MBI 226 Acne Solutions

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, acne vulgaris, MBI 226, Propionibacterium acnes, lesion counts, lesions, inflammatory, non-inflammatory, topical

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females, ages 13 and up, exhibiting high levels of facial P. acnes Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.) Active facial cysts

Sites / Locations

Outcomes

Primary Outcome Measures

- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment

Secondary Outcome Measures

- percent change in lesion counts after ~2 and ~4 weeks

- Global Severity Assessment

Full Information

NCT ID

NCT00211523

First Posted

September 13, 2005

Last Updated

September 13, 2005

Sponsor

BioWest Therapeutics Inc

1. Study Identification

Unique Protocol Identification Number

NCT00211523

Brief Title

Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

Official Title

Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

BioWest Therapeutics Inc

4. Oversight

5. Study Description

Brief Summary

This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris, Acne, Propionibacterium Acnes

Keywords

acne, acne vulgaris, MBI 226, Propionibacterium acnes, lesion counts, lesions, inflammatory, non-inflammatory, topical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

75 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MBI 226 Acne Solutions

Primary Outcome Measure Information:

Title

- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment

Secondary Outcome Measure Information:

Title

- percent change in lesion counts after ~2 and ~4 weeks

Title

- Global Severity Assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim Pankovich

Organizational Affiliation

BioWest Therapeutics Inc

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

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