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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: BLI1100 - modified formulation; Drug: Placebo; Drug: BLI1100

• Registration Number: NCT01815450
• Lead Sponsor: Braintree Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Primary Completion: 2013-11
• Status Verified: 2015-01
• Disposition First Submitted: 2015-01-26
• Disposition First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Disposition First Posted: 2015-02-02
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BLI1100 - modified formulation	BLI1100 - modified formulation	BLI1100 topical cream
Placebo	Placebo	Topical cream
BLI1100	BLI1100	BLI1100 topical cream

Primary Outcome Measures

Name	Time	Method
Change in total lesion count	Baseline to Week 12

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Center for Dermatology Clincal Research; 🇺🇸 Fremont, California, United States

North Florida Dermatology Associates; 🇺🇸 Jacksonville, Florida, United States

Ameriderm Research; 🇺🇸 Ormond Beach, Florida, United States

Peachtree Dermatology Associates Research Center; 🇺🇸 Atlanta, Georgia, United States

The Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

Great Lakes Research Group, Inc.; 🇺🇸 Bay City, Michigan, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Academic Dermatology Associates; 🇺🇸 Albuquerque, New Mexico, United States

Clinical Partners; 🇺🇸 Johnston, Rhode Island, United States

DiscoveResearch; 🇺🇸 Bryan, Texas, United States

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