A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02608476|
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: CB-03-01 cream, 1% Drug: Vehicle cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: CB-03-01 cream
CB-03-01 cream, 1% applied twice daily for 12 weeks
Drug: CB-03-01 cream, 1%
CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Other Name: cortexolone 17α-propionate
Placebo Comparator: Vehicle cream
Vehicle cream applied twice daily for 12 weeks
Drug: Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
- Success rate in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]Proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
- Change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
- Change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
- Change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
- Percent change from baseline in total lesion counts [ Time Frame: Baseline and Week 12 ]Percent change from Baseline in total lesions counts in each treatment group at Week 12.
- Percent change from baseline in non-inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
- Percent change from baseline in inflammatory lesion counts [ Time Frame: Baseline and Week 12 ]Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
- Local Site Reactions [ Time Frame: Baseline, Weeks 4, 8, and 12 ]Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).
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): NCT02608476
|Contact: Nicoletta Coceaniemail@example.com|
|Contact: Katrina Kokjohnfirstname.lastname@example.org|
|United States, Arizona|
|Johnson Dermatology||Active, not recruiting|
|Fort Smith, Arizona, United States, 72916|
|Clear dermatology & Aesthetic Center||Active, not recruiting|
|Scottsdale, Arizona, United States, 85255|
|United States, California|
|Center for Dermatology and Laser Surgery||Active, not recruiting|
|Sacramento, California, United States, 95819|
|United States, Florida|
|Belleair Research Center||Active, not recruiting|
|Pinellas Park, Florida, United States, 33781|
|United States, Illinois|
|Arlington Dermatology||Active, not recruiting|
|Arlington Heights, Illinois, United States, 60005|
|United States, Kansas|
|Kansas City Dermatology, PA||Active, not recruiting|
|Overland Park, Kansas, United States, 66215|
|United States, Maryland|
|Maryland Laser Skin and Vein Institute||Active, not recruiting|
|Hunt Valley, Maryland, United States, 21030|
|United States, New York|
|Sadick Research Group, LLC||Active, not recruiting|
|New York, New York, United States, 10075|
|Skin Specialty Dermatology||Recruiting|
|New York, New York, United States, 10155|
|Contact: Okechukwu Udogu, MD, MPH 212-223-6599 email@example.com|
|Principal Investigator: Fran Cook-Bolden, MD|
|United States, Rhode Island|
|Clinical Partners, LLC||Active, not recruiting|
|Johnston, Rhode Island, United States, 02919|
|United States, Texas|
|Texas Dermatology and Laser Specialists||Recruiting|
|San Antonio, Texas, United States, 78218|
|Contact: Carla Ilie carla@TexasDLS.com|
|Principal Investigator: John Browning, MD|
|Progressive Clinical Research, PA||Active, not recruiting|
|San Antonio, Texas, United States, 78229|
|Study Director:||Louise Dube, PhD||Cassiopea S.p.A.|