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CompletedNCT01815450Updated Feb 2, 2015

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

A Phase 2 interventional study of BLI1100 and BLI1100 - modified formulation in Acne Vulgaris, sponsored by Braintree Laboratories. Completed at 15 sites in United States. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-02-02.

Sponsored by Braintree Laboratories · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
369
Allocation
Randomized
Ages
12 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 369 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Braintree Laboratories is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
369 participants (actual)

Study arms

  • Experimental
    BLI1100

    BLI1100 topical cream

    Drug: BLI1100

  • Experimental
    BLI1100 - modified formulation

    BLI1100 topical cream

    Drug: BLI1100 - modified formulation

  • Placebo comparator
    Placebo

    Topical cream

    Drug: Placebo

Interventions

  • DrugBLI1100

    BLI1100 topical cream

  • DrugBLI1100 - modified formulation

    BLI1100 topical cream

  • DrugPlacebo

    Placebo topical cream

06

What researchers measure

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

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

    Time frame: 12 weeks

  3. Local Tolerability Score

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

    Time frame: 12 weeks

07

Study locations

15 sites
  • Center for Dermatology Clincal Research
    Fremont, California 94538, United States
  • North Florida Dermatology Associates
    Jacksonville, Florida 32204, United States
  • Ameriderm Research
    Ormond Beach, Florida 32174, United States
  • Peachtree Dermatology Associates Research Center
    Atlanta, Georgia 30327, United States
  • The Indiana Clinical Trials Center
    Plainfield, Indiana 46168, United States
  • Great Lakes Research Group, Inc.
    Bay City, Michigan 48706, United States
  • Minnesota Clinical Study Center
    Fridley, Minnesota 55432, United States
  • Academic Dermatology Associates
    Albuquerque, New Mexico 87106, United States
  • Clinical Partners
    Johnston, Rhode Island 02919, United States
  • DiscoveResearch
    Bryan, Texas 77802, United States
  • Suzanne Bruce and Associates
    Houston, Texas 77056, United States
  • Dermatology Research Center
    Salt Lake City, Utah 84124, United States
  • The Education and Research Foundation
    Lynchburg, Virginia 24501, United States
  • Women's Clinical Research Center
    Seattle, Washington 98105, United States
  • Premier Clinical Research
    Spokane, Washington 99204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01815450
Lead sponsor
Braintree Laboratories
Responsible party
Sponsor
First posted
Mar 21, 2013
Start date
Feb 2013
Primary completion
Nov 2013
Last update
Feb 2, 2015

Study contacts

John McGowan, MPH
study director · Braintree Laboratories, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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