A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

Study Overview
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Brief Summary
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The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CB-03-01 cream, 1%
* Drug: Vehicle cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale]. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones). Subject and parent/guardian (if applicable) are 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 (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit 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 has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy. Subject has greater than two (2) facial nodules. Subject has nodulocystic acne. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. Subject is currently enrolled in an investigational drug or device study. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline). Subject has facial hair that could interfere with the study assessments in the opinion of the investigator. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CB-03-01 cream<br>CB-03-01 cream, 1% applied twice daily for 12 weeks | Drug: CB-03-01 cream, 1%<br>* 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.<br>* Other names: clascoterone (USAN, INN);|
| Placebo Comparator: Vehicle cream<br>Vehicle cream applied twice daily for 12 weeks | Drug: Vehicle cream<br>* Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) | Percentage 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. | Week 12 | 
| Change From Baseline in Non-inflammatory Lesion Counts | Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12. | Baseline and Week 12 | 
| Change From Baseline in Inflammatory Lesion Counts | Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Lesion Counts | Absolute change from Baseline in total lesions counts in each treatment group at Week 12. | Baseline and Week 12 | 
| Percent Change From Baseline in Total Lesion Counts | Percent change from Baseline in total lesions counts in each treatment group at Week 12. | Baseline and Week 12 | 
| Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts | Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12. | Baseline and Week 12 | 
| Percent Change From Baseline in Inflammatory Lesion (IL) Counts | Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, clascoterone, anti-androgen