BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT01241331 |
Recruitment Status :
Completed
First Posted : November 16, 2010
Last Update Posted : October 1, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: BLI1100 Drug: Vehicle cream | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 233 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Controlled Evaluation of the Safety and Efficacy of a Topical Treatment for Moderate-Severe Facial Acne Vulgaris |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | April 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: BLI1100
BLI1100 topical cream
|
Drug: BLI1100
BLI110 topical cream |
Placebo Comparator: Vehicle cream
Vehicle topical cream
|
Drug: Vehicle cream
Vehicle topical cream |
- percent reduction of total acne lesion counts [ Time Frame: 12 weeks ]
- 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.
- Change in serum chemistry [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 12 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241331

Responsible Party: | Braintree Laboratories |
ClinicalTrials.gov Identifier: | NCT01241331 |
Other Study ID Numbers: |
BLI1100-201 |
First Posted: | November 16, 2010 Key Record Dates |
Last Update Posted: | October 1, 2012 |
Last Verified: | September 2012 |
moderate to severe facial acne vulgaris |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |