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OpenTrials
Completed

NCT Number: NCT01241331

BLI1100 for the Treatment of Moderate to Severe 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Dermatology Clincal Research, Fremont, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BLI1100

Drug

BLI110 topical cream

Vehicle cream

Drug

Vehicle topical cream

Primary outcomes

  1. percent reduction of total acne lesion counts

    Time frame: 12 weeks

Secondary outcomes

  1. Investigator's Global Assessment

    Time frame: 12

    Rating of overall facial acne on a 4 point scale (0=clear to 4=severe) performed by a blinded investigator.

  2. Change in serum chemistry

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris

Important dates

Study start
2010
Primary completion
2011
First posted
Nov 16, 2010
Registry last updated
Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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