BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Vehicle cream; Drug: BLI1100

• Registration Number: NCT01241331
• Lead Sponsor: Braintree Laboratories

Brief Summary

The purpose of this study is to compare the safety and efficacy of formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2011-04
• Status Verified: 2012-09
• Disposition First Submitted: 2012-09-27
• Disposition First Submitted QC: 2012-09-27
• Last Update Submitted: 2012-09-27
• Disposition First Posted: 2012-10-01
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Qualifying Investigator's Global Assessment severity score
• Qualifying number of non-inflammatory lesions
• Qualifying number of inflammatory lesions

Exclusion Criteria

• Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
• Using medications that are reported to exacerbate acne
• Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
• Have a known hypersensitivity or previous allergic reaction to any of the components
• Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
• Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle cream	Vehicle cream	Vehicle topical cream
BLI1100	BLI1100	BLI1100 topical cream

Primary Outcome Measures

Name	Time	Method
percent reduction of total acne lesion counts	12 weeks

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Assessment	12	Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.
Change in serum chemistry	12 weeks

Trial Locations

Locations (20)

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

The South Bend Clinic; 🇺🇸 South Bend, Indiana, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

The Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

Virginia Clinical Research; 🇺🇸 Norfolk, Virginia, United States

Northwest Clinical Trials; 🇺🇸 Nampa, Idaho, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Clinical Partners; 🇺🇸 Johnston, Rhode Island, United States

Dermatology Specialists; 🇺🇸 Oceanside, California, United States

Peachtree Dermatology Associates Research Center; 🇺🇸 Atlanta, Georgia, United States

North Florida Dermatology Associates; 🇺🇸 Jacksonville, Florida, United States

DiscoveResearch; 🇺🇸 Bryan, Texas, United States

Premier Clinical Research; 🇺🇸 Spokane, Washington, United States

Center for Dermatology Clincal Research; 🇺🇸 Fremont, California, United States

Horizons Clinical Research Center; 🇺🇸 Denver, Colorado, United States

Progressive Clinical Research; 🇺🇸 San Antonio, Texas, United States

Dermatology Research Center; 🇺🇸 Salt Lake City, Utah, United States

Atlanta Dermatology, Vein and Research Center; 🇺🇸 Alpharetta, Georgia, United States

The Education and Research Foundation; 🇺🇸 Lynchburg, Virginia, United States