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Completed

NCT Number: NCT00211497

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

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.

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Key information

Conditions

Acne Vulgaris Acne Acneiform Eruptions Propionibacterium Acnes Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBI 226 Acne Solutions

Drug

Primary outcomes

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

Secondary outcomes

  1. Single continuous endpoints:

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

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

  4. Multiple continuous endpoints:

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

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

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

  8. Categorical endpoints:

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

  10. • PGSA absolute scores at Week 6 and Week 12

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

Sponsors and collaborators

Lead sponsor

BioWest Therapeutics Inc

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2003
First posted
Sep 21, 2005
Registry last updated
Sep 21, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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