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Safety and Efficacy of MBI 226 1.25% and 2.5% 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
Sponsored by
BioWest Therapeutics Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    September 13, 2005
    Sponsor
    BioWest Therapeutics Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00211497
    Brief Title
    Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
    Official Title
    A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    BioWest Therapeutics Inc

    4. Oversight

    5. Study Description

    Brief Summary
    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.

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    255 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MBI 226 Acne Solutions
    Primary Outcome Measure Information:
    Title
    - percent change from Baseline to Week 12 in inflammatory acne lesion counts
    Secondary Outcome Measure Information:
    Title
    Single continuous endpoints:
    Title
    • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
    Title
    • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
    Title
    Multiple continuous endpoints:
    Title
    • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
    Title
    • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
    Title
    • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
    Title
    Categorical endpoints:
    Title
    • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
    Title
    • PGSA absolute scores at Week 6 and Week 12
    Title
    • PGSA absolute scores over Baseline, Week 6 and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    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 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

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