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

• ClinicalTrials.gov Identifier: NCT01631474
• Recruitment Status: Completed
• First Posted: June 29, 2012
• Last Update Posted: April 16, 2015
• Sponsor: Intrepid Therapeutics, Inc.
• Information provided by (Responsible Party): Intrepid Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: CB-03-01; Drug: Vehicle	Phase 2

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low-dose active, BID; low dose of CB-03-01, applied twice a day	Drug: CB-03-01; Topical cream, applied twice a day
Experimental: Medium-dose active, BID; medium dose of CB-03-01, applied twice a day	Drug: CB-03-01; Topical cream, applied twice a day
Experimental: High-dose active, QD; high dose of CB-03-01, applied once a day	Drug: CB-03-01; Topical cream, applied once a day
Experimental: High-dose active, BID; high dose of CB-03-01, applied twice a day	Drug: CB-03-01; Topical cream, applied twice a day
Placebo Comparator: Vehicle, QD or BID; vehicle cream, applied once or twice a day	Drug: Vehicle; Topical cream, applied once or twice a day

Outcome Measures

Primary Outcome Measures :

1. Investigator's Global Assessment (IGA) "Success" - Week 12 [ Time Frame: Baseline and Week 12 ]
   Proportion 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.
2. 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.

Secondary Outcome Measures :

1. 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.
2. Total Lesion Counts - Weeks 8 and 12 [ Time Frame: Baseline, Week 8 and Week 12 ]
   Percent change from Baseline in lesion counts in each treatment group at Weeks 8 and 12.
3. IGA "Success" - Week 8 [ Time Frame: Baseline and Week 8 ]
   Proportion of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
4. IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12 [ Time Frame: Baseline, Week 4, Week 8 and Week 12 ]
   Proportion of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Intrepid Therapeutics, Inc.

Investigators

• Study Director: Syd Dromgoole, PhD; Therapeutics, Inc.

More Information

• Responsible Party: Intrepid Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT01631474
• Other Study ID Numbers: 171-7151-201
• First Posted: June 29, 2012
• Last Update Posted: April 16, 2015
• Last Verified: March 2015

Keywords provided by Intrepid Therapeutics, Inc.:

Intrepid; acne; antiandrogen

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases