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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: CB-03-01; Drug: CB-03-01; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 363
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Diego, California, United States, 92123
      • University Clinical Trials
  • Florida
    • Sanford, Florida, United States
      • International Clinical Research - US, LLC
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc.
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trials Center
  • New York
    • Smithtown, New York, United States
      • Marina I. Peredo, M.D., PC
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
  • Rhode Island
    • Johnston, Rhode Island, United States
      • Clinical Partners, LLC
  • Texas
    • College Station, Texas, United States, 77845
      • J & S Studies
    • Houston, Texas, United States, 77030
      • UT Houston Health Science Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose active, BID; low dose of CB-03-01, 0.1% applied twice a day	Drug: CB-03-01; Topical cream, applied once a day; Other Names: clascoterone; Drug: CB-03-01; Topical cream, applied twice a day; Other Names: 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 once a day; Other Names: clascoterone; Drug: CB-03-01; Topical cream, applied twice a day; Other Names: 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 Names: clascoterone; Drug: CB-03-01; Topical cream, applied twice a day; Other Names: clascoterone
Experimental: High-dose active, BID; high dose of CB-03-01, 1% applied twice a day	Drug: CB-03-01; Topical cream, applied once a day; Other Names: clascoterone; Drug: CB-03-01; Topical cream, applied twice a day; Other Names: 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

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

Collaborators and Investigators

• Sponsor: Intrepid Therapeutics, Inc.
• Investigators: Study Director: R&D Cassiopea, Cassiopea S.p.A.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 27, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (Estimate): June 29, 2012

Study Record Updates

• Last Update Posted (Actual): November 16, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: acne; anti-androgen; clascoterone; cassiopea
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 171-7151-201