NCT00211497

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Acne VulgarisAcnePropionibacterium Acnes

Keywords

acne vulgarisacnePropionibacterium acnestopicalinflammatorynon-inflammatorylesion countslesions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Interventions

MBI 226 Acne SolutionsDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Jim Pankovich

    BioWest Therapeutics Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2003

Study Completion

September 1, 2003

Last Updated

September 21, 2005

Record last verified: 2005-09