Clinical trial NCT01815450: BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2013-03-21
Enrollment: 369
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 BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Males or females 12 to 45 years of age with facial acne vulgaris
* 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: Change in total lesion count
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percent change in total lesion count
timeFrame: Baseline to Week 12
measure: Investigator's Global Assessment
timeFrame: 12 weeks
measure: Local Tolerability Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clincal Research
state: California
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates Research Center
state: Georgia
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
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: Houston
country: United States
facility: Suzanne Bruce and Associates
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: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References: