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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: BLI1100; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clincal Research
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Oceanside, California, United States, 92056
      • Dermatology Specialists
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein and Research Center
    • Atlanta, Georgia, United States, 30327
      • Peachtree Dermatology Associates Research Center
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Northwest Clinical Trials
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners
  • Texas
    • Bryan, Texas, United States, 77802
      • DiscoveResearch
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI1100; BLI1100 topical cream	Drug: BLI1100; BLI110 topical cream
Placebo Comparator: Vehicle cream; Vehicle topical cream	Drug: Vehicle cream; Vehicle topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percent reduction of total acne lesion counts	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's Global Assessment	Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.	12
Change in serum chemistry		12 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: November 11, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: moderate to severe facial acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: BLI1100-201