BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: BLI1100; Drug: BLI1100 - modified formulation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clincal Research
  • Florida
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Peachtree Dermatology Associates Research Center
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
  • 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
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center
    • 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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI1100; BLI1100 topical cream	Drug: BLI1100; BLI1100 topical cream
Experimental: BLI1100 - modified formulation; BLI1100 topical cream	Drug: BLI1100 - modified formulation; BLI1100 topical cream
Placebo Comparator: Placebo; Topical cream	Drug: Placebo; Placebo topical cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total lesion count	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in total lesion count		Baseline to Week 12
Investigator's Global Assessment	Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)	12 weeks
Local Tolerability Score	Rating of facial symptoms on a 4 point scale (0=none, 3=severe)	12 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: BLI1100-202