BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris
1 other identifier
interventional
233
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 11, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedOctober 1, 2012
September 1, 2012
5 months
November 11, 2010
September 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percent reduction of total acne lesion counts
12 weeks
Secondary Outcomes (2)
Investigator's Global Assessment
12
Change in serum chemistry
12 weeks
Study Arms (2)
BLI1100
EXPERIMENTALBLI1100 topical cream
Vehicle cream
PLACEBO COMPARATORVehicle topical cream
Interventions
Eligibility Criteria
You may qualify if:
- Qualifying Investigator's Global Assessment severity score
- Qualifying number of non-inflammatory lesions
- Qualifying number of inflammatory lesions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Center for Dermatology Clincal Research
Fremont, California, 94538, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Specialists
Oceanside, California, 92056, United States
Horizons Clinical Research Center
Denver, Colorado, 80220, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
Ameriderm Research
Ormond Beach, Florida, 32174, United States
Atlanta Dermatology, Vein and Research Center
Alpharetta, Georgia, 30022, United States
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, 30327, United States
Northwest Clinical Trials
Nampa, Idaho, 83686, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
The South Bend Clinic
South Bend, Indiana, 46617, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Clinical Partners
Johnston, Rhode Island, 02919, United States
DiscoveResearch
Bryan, Texas, 77802, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Dermatology Research Center
Salt Lake City, Utah, 84124, United States
The Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2010
First Posted
November 16, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2011
Last Updated
October 1, 2012
Record last verified: 2012-09