A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01631474 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Results First Posted : November 16, 2020
Last Update Posted : November 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: CB-03-01 Drug: Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 363 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Low-dose active, BID
low dose of CB-03-01, 0.1% applied twice a day
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Drug: CB-03-01
Topical cream, applied twice a day
Other Name: clascoterone |
Experimental: Medium-dose active, BID
medium dose of CB-03-01, 0.5% applied twice a day
|
Drug: CB-03-01
Topical cream, applied twice a day
Other Name: clascoterone |
Experimental: High-dose active, QD
high dose of CB-03-01, 1% applied once a day
|
Drug: CB-03-01
Topical cream, applied once a day
Other Name: clascoterone |
Experimental: High-dose active, BID
high dose of CB-03-01, 1% applied twice a day
|
Drug: CB-03-01
Topical cream, applied twice a day
Other Name: clascoterone |
Placebo Comparator: Vehicle, QD or BID
vehicle cream, applied once or twice a day
|
Drug: Vehicle
Topical cream, applied once or twice a day |
- Investigator's Global Assessment (IGA) "Success" - Week 12 [ Time Frame: Baseline and Week 12 ]Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
- Inflammatory and Non-Inflammatory Lesion Counts - Week 12 [ Time Frame: Baseline and Week 12 ]Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
- Inflammatory and Non-Inflammatory Lesion Counts - Week 8 [ Time Frame: Baseline and Week 8 ]Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
- Percent Change in Lesion Counts - Weeks 8 and 12 [ Time Frame: Week 8 and Week 12 ]Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
- IGA "Success" - Week 8 [ Time Frame: Baseline and Week 8 ]Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
- IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12 [ Time Frame: Weeks 4, 8, and 12 ]Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
- Subject has provided written and verbal informed consent/assent.
- Subject has facial acne vulgaris (including the nose).
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
Exclusion Criteria:
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
- Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial
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Subject has used any of the following topical anti-acne preparations or procedures on the face:
- Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
- Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
- Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
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Subject has used the following systemic anti-acne medications:
- Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
- Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
- Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
- Retinoid therapy within six months of the initiation of treatment.

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): NCT01631474
United States, California | |
Dermatology Research Associates | |
Los Angeles, California, United States, 90045 | |
Therapeutics Clinical Research | |
San Diego, California, United States, 92123 | |
University Clinical Trials | |
San Diego, California, United States, 92123 | |
United States, Florida | |
International Clinical Research - US, LLC | |
Sanford, Florida, United States | |
United States, Georgia | |
Gwinnett Clinical Research Center, Inc. | |
Snellville, Georgia, United States, 30078 | |
United States, Illinois | |
Altman Dermatology Associates | |
Arlington Heights, Illinois, United States, 60005 | |
United States, Indiana | |
Indiana Clinical Trials Center | |
Plainfield, Indiana, United States, 46168 | |
United States, New York | |
Marina I. Peredo, M.D., PC | |
Smithtown, New York, United States | |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center - Dept. of Dermatology | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Rhode Island | |
Clinical Partners, LLC | |
Johnston, Rhode Island, United States | |
United States, Texas | |
J & S Studies | |
College Station, Texas, United States, 77845 | |
UT Houston Health Science Center | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Clinical Research | |
Norfolk, Virginia, United States, 23507 |
Study Director: | R&D Cassiopea | Cassiopea S.p.A. |
Responsible Party: | Intrepid Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01631474 |
Other Study ID Numbers: |
171-7151-201 |
First Posted: | June 29, 2012 Key Record Dates |
Results First Posted: | November 16, 2020 |
Last Update Posted: | November 16, 2020 |
Last Verified: | October 2020 |
acne anti-androgen clascoterone cassiopea |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |