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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01815450

Enrollment

369

Registered

2013-03-21

Start date

2013-02-28

Completion date

Unknown

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DRUGBLI1100

BLI1100 topical cream

DRUGBLI1100 - modified formulation

BLI1100 topical cream

DRUGPlacebo

Placebo topical cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in total lesion count	Baseline to Week 12

Secondary

Measure	Time frame	Description
Percent change in total lesion count	Baseline to Week 12	—
Investigator's Global Assessment	12 weeks	Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)
Local Tolerability Score	12 weeks	Rating of facial symptoms on a 4 point scale (0=none, 3=severe)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026