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OpenTrials
Completed

NCT Number: NCT01815450

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.

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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

  • 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

Treatment and study plan

BLI1100

Drug

BLI1100 topical cream

BLI1100 - modified formulation

Drug

BLI1100 topical cream

Placebo

Drug

Placebo topical cream

Primary outcomes

  1. Change in total lesion count

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Percent change in total lesion count

    Time frame: Baseline to Week 12

  2. Investigator's Global Assessment

    Time frame: 12 weeks

    Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)

  3. Local Tolerability Score

    Time frame: 12 weeks

    Rating of facial symptoms on a 4 point scale (0=none, 3=severe)

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
First posted
Mar 21, 2013
Registry last updated
Feb 2, 2015

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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