search
Back to results

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
Vehicle cream
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring moderate to severe facial acne vulgaris

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Dermatology Clincal Research
  • Dermatology Research Associates
  • Dermatology Specialists
  • Horizons Clinical Research Center
  • North Florida Dermatology Associates
  • Ameriderm Research
  • Atlanta Dermatology, Vein and Research Center
  • Peachtree Dermatology Associates Research Center
  • Northwest Clinical Trials
  • The Indiana Clinical Trials Center
  • The South Bend Clinic
  • Minnesota Clinical Study Center
  • Academic Dermatology Associates
  • Clinical Partners
  • DiscoveResearch
  • Progressive Clinical Research
  • Dermatology Research Center
  • The Education and Research Foundation
  • Virginia Clinical Research
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BLI1100

Vehicle cream

Arm Description

BLI1100 topical cream

Vehicle topical cream

Outcomes

Primary Outcome Measures

percent reduction of total acne lesion counts

Secondary Outcome Measures

Investigator's Global Assessment
Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.
Change in serum chemistry

Full Information

First Posted
November 11, 2010
Last Updated
September 27, 2012
Sponsor
Braintree Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT01241331
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (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 formulation BLI1100 to its vehicle in the treatment of moderate-severe acne vulgaris.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
moderate to severe facial acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLI1100
Arm Type
Experimental
Arm Description
BLI1100 topical cream
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Description
Vehicle topical cream
Intervention Type
Drug
Intervention Name(s)
BLI1100
Intervention Description
BLI110 topical cream
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle topical cream
Primary Outcome Measure Information:
Title
percent reduction of total acne lesion counts
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment
Description
Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.
Time Frame
12
Title
Change in serum chemistry
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: 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
Facility Information:
Facility Name
Center for Dermatology Clincal Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Dermatology Specialists
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Horizons Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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
Atlanta Dermatology, Vein and Research Center
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Peachtree Dermatology Associates Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Northwest Clinical Trials
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
The South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
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
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Virginia Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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 for the Treatment of Moderate to Severe Acne Vulgaris

We'll reach out to this number within 24 hrs