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

BioWest Therapeutics Inc255 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

255

Conditions

Acne Vulgaris Acne Propionibacterium Acnes

Interventions

MBI 226 Acne SolutionsDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

- percent change from Baseline to Week 12 in inflammatory acne lesion counts

Secondary Outcomes

Single continuous endpoints:

• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts

• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts

Multiple continuous endpoints:

• Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts

• Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts

• Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts

Categorical endpoints:

• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12

• PGSA absolute scores at Week 6 and Week 12

• PGSA absolute scores over Baseline, Week 6 and Week 12

Data from ClinicalTrials.gov

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