Clinical trial NCT01241331: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Official title: A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: moderate to severe facial acne vulgaris
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 233
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: percent reduction of total acne lesion counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigator's Global Assessment
timeFrame: 12
measure: Change in serum chemistry
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clincal Research
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein and Research Center
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates Research Center
state: Georgia
city: Nampa
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Johnston
country: United States
facility: Clinical Partners
state: Rhode Island
city: Bryan
country: United States
facility: DiscoveResearch
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References: