A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.

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

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: CB-03-01
* Drug: Vehicle
* Drug: CB-03-01


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose active, BID<br>low dose of CB-03-01, 0.1% applied twice a day | Drug: CB-03-01<br>* Topical cream, applied twice a day<br>* Other names: clascoterone;|
| Experimental: Medium-dose active, BID<br>medium dose of CB-03-01, 0.5% applied twice a day | Drug: CB-03-01<br>* Topical cream, applied twice a day<br>* Other names: clascoterone;|
| Experimental: High-dose active, QD<br>high dose of CB-03-01, 1% applied once a day | Drug: CB-03-01<br>* Topical cream, applied once a day<br>* Other names: clascoterone;|
| Experimental: High-dose active, BID<br>high dose of CB-03-01, 1% applied twice a day | Drug: CB-03-01<br>* Topical cream, applied twice a day<br>* Other names: clascoterone;|
| Placebo Comparator: Vehicle, QD or BID<br>vehicle cream, applied once or twice a day | Drug: Vehicle<br>* Topical cream, applied once or twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8. | Baseline and Week 8 | 
| Percent Change in Lesion Counts - Weeks 8 and 12 | Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12. | Week 8 and Week 12 | 
| IGA Success - 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). | Baseline and Week 8 | 
| IGA Clear or Almost Clear - 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. | Weeks 4, 8, and 12 | 

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