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NCT01241331 Clinical Trial

BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:
A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01241331
Other study ID # BLI1100-201
Secondary ID
Status Completed
Phase Phase 2
First received November 11, 2010
Last updated September 27, 2012
Start date November 2010

Study information
Verified date September 2012
Source Braintree Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 233
Est. completion date
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 45 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• BLI1100
BLI110 topical cream
• Vehicle cream
Vehicle topical cream

Locations
Country Name City State
United States Academic Dermatology Associates Albuquerque New Mexico
United States Atlanta Dermatology, Vein and Research Center Alpharetta Georgia
United States Peachtree Dermatology Associates Research Center Atlanta Georgia
United States DiscoveResearch Bryan Texas
United States Horizons Clinical Research Center Denver Colorado
United States Center for Dermatology Clincal Research Fremont California
United States Minnesota Clinical Study Center Fridley Minnesota
United States North Florida Dermatology Associates Jacksonville Florida
United States Clinical Partners Johnston Rhode Island
United States Dermatology Research Associates Los Angeles California
United States The Education and Research Foundation Lynchburg Virginia
United States Northwest Clinical Trials Nampa Idaho
United States Virginia Clinical Research Norfolk Virginia
United States Dermatology Specialists Oceanside California
United States Ameriderm Research Ormond Beach Florida
United States The Indiana Clinical Trials Center Plainfield Indiana
United States Dermatology Research Center Salt Lake City Utah
United States Progressive Clinical Research San Antonio Texas
United States The South Bend Clinic South Bend Indiana
United States Premier Clinical Research Spokane Washington

Sponsors (1)
Lead Sponsor Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary percent reduction of total acne lesion counts 12 weeks No
Secondary Investigator's Global Assessment Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator. 12 No
Secondary Change in serum chemistry 12 weeks Yes
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