NCT01815450

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

March 18, 2013

Last Update Submit

January 26, 2015

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Change in total lesion count

    Baseline to Week 12

Secondary Outcomes (3)

  • Percent change in total lesion count

    Baseline to Week 12

  • Investigator's Global Assessment

    12 weeks

  • Local Tolerability Score

    12 weeks

Study Arms (3)

BLI1100

EXPERIMENTAL

BLI1100 topical cream

Drug: BLI1100

BLI1100 - modified formulation

EXPERIMENTAL

BLI1100 topical cream

Drug: BLI1100 - modified formulation

Placebo

PLACEBO COMPARATOR

Topical cream

Drug: Placebo

Interventions

BLI1100DRUG

BLI1100 topical cream

BLI1100
BLI1100 - modified formulationDRUG

BLI1100 topical cream

BLI1100 - modified formulation
PlaceboDRUG

Placebo topical cream

Placebo

Eligibility Criteria

Age12 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Center for Dermatology Clincal Research

Fremont, California, 94538, United States

Location

North Florida Dermatology Associates

Jacksonville, Florida, 32204, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Peachtree Dermatology Associates Research Center

Atlanta, Georgia, 30327, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Clinical Partners

Johnston, Rhode Island, 02919, United States

Location

DiscoveResearch

Bryan, Texas, 77802, United States

Location

Suzanne Bruce and Associates

Houston, Texas, 77056, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

The Education and Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • John McGowan, MPH

    Braintree Laboratories, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 21, 2013

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

US(15)