BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

NCT ID: NCT01241331

Last Updated: 2012-10-01

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

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris

Keywords

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moderate to severe facial acne vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BLI1100

BLI1100 topical cream

Group Type EXPERIMENTAL

BLI1100

Intervention Type DRUG

BLI110 topical cream

Vehicle cream

Vehicle topical cream

Group Type PLACEBO_COMPARATOR

Vehicle cream

Intervention Type DRUG

Vehicle topical cream

Interventions

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BLI1100

BLI110 topical cream

Intervention Type DRUG

Vehicle cream

Vehicle topical cream

Intervention Type DRUG

Eligibility Criteria

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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
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

Locations

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Center for Dermatology Clincal Research

Fremont, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Dermatology Specialists

Oceanside, California, United States

Site Status

Horizons Clinical Research Center

Denver, Colorado, United States

Site Status

North Florida Dermatology Associates

Jacksonville, Florida, United States

Site Status

Ameriderm Research

Ormond Beach, Florida, United States

Site Status

Atlanta Dermatology, Vein and Research Center

Alpharetta, Georgia, United States

Site Status

Peachtree Dermatology Associates Research Center

Atlanta, Georgia, United States

Site Status

Northwest Clinical Trials

Nampa, Idaho, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

The South Bend Clinic

South Bend, Indiana, 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

Progressive Clinical Research

San Antonio, 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

Virginia Clinical Research

Norfolk, Virginia, 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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BLI1100-201

Identifier Type: -

Identifier Source: org_study_id