Back to resultsBLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BLI1100
BLI1100 - modified formulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Center for Dermatology Clincal Research
- North Florida Dermatology Associates
- Ameriderm Research
- Peachtree Dermatology Associates Research Center
- The Indiana Clinical Trials Center
- Great Lakes Research Group, Inc.
- Minnesota Clinical Study Center
- Academic Dermatology Associates
- Clinical Partners
- DiscoveResearch
- Suzanne Bruce and Associates
- Dermatology Research Center
- The Education and Research Foundation
- Women's Clinical Research Center
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BLI1100
BLI1100 - modified formulation
Placebo
Arm Description
BLI1100 topical cream
BLI1100 topical cream
Topical cream
Outcomes
Primary Outcome Measures
Change in total lesion count
Secondary Outcome Measures
Percent change in total lesion count
Investigator's Global Assessment
Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)
Local Tolerability Score
Rating of facial symptoms on a 4 point scale (0=none, 3=severe)
Full Information
NCT ID
NCT01815450
First Posted
March 18, 2013
Last Updated
January 26, 2015
Sponsor
Braintree Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01815450
Brief Title
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
369 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BLI1100
Arm Type
Experimental
Arm Description
BLI1100 topical cream
Arm Title
BLI1100 - modified formulation
Arm Type
Experimental
Arm Description
BLI1100 topical cream
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical cream
Intervention Type
Drug
Intervention Name(s)
BLI1100
Intervention Description
BLI1100 topical cream
Intervention Type
Drug
Intervention Name(s)
BLI1100 - modified formulation
Intervention Description
BLI1100 topical cream
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo topical cream
Primary Outcome Measure Information:
Title
Change in total lesion count
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percent change in total lesion count
Time Frame
Baseline to Week 12
Title
Investigator's Global Assessment
Description
Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)
Time Frame
12 weeks
Title
Local Tolerability Score
Description
Rating of facial symptoms on a 4 point scale (0=none, 3=severe)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McGowan, MPH
Organizational Affiliation
Braintree Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Center for Dermatology Clincal Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
North Florida Dermatology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Peachtree Dermatology Associates Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Clinical Partners
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
DiscoveResearch
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Suzanne Bruce and Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education and Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
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