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
• 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. 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

• Acne Vulgaris

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