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

NCT ID: NCT01815450

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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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

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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BLI1100

BLI1100 topical cream

Group Type EXPERIMENTAL

BLI1100

Intervention Type DRUG

BLI1100 topical cream

BLI1100 - modified formulation

BLI1100 topical cream

Group Type EXPERIMENTAL

BLI1100 - modified formulation

Intervention Type DRUG

BLI1100 topical cream

Placebo

Topical cream

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo topical cream

Interventions

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BLI1100

BLI1100 topical cream

Intervention Type DRUG

BLI1100 - modified formulation

BLI1100 topical cream

Intervention Type DRUG

Placebo

Placebo topical cream

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Braintree Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John McGowan, MPH

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

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Center for Dermatology Clincal Research

Fremont, California, United States

Site Status

North Florida Dermatology Associates

Jacksonville, Florida, United States

Site Status

Ameriderm Research

Ormond Beach, Florida, United States

Site Status

Peachtree Dermatology Associates Research Center

Atlanta, Georgia, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Clinical Partners

Johnston, Rhode Island, United States

Site Status

DiscoveResearch

Bryan, Texas, United States

Site Status

Suzanne Bruce and Associates

Houston, Texas, United States

Site Status

Dermatology Research Center

Salt Lake City, Utah, United States

Site Status

The Education and Research Foundation

Lynchburg, Virginia, United States

Site Status

Women's Clinical Research Center

Seattle, Washington, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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BLI1100-202

Identifier Type: -

Identifier Source: org_study_id

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