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

NCT ID: NCT01631474

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-02-28

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.

Conditions

Acne Vulgaris

Keywords

acne; anti-androgen; clascoterone; cassiopea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-dose active, BID

low dose of CB-03-01, 0.1% applied twice a day

Group Type: EXPERIMENTAL

CB-03-01

Intervention Type: DRUG

Topical cream, applied twice a day

Medium-dose active, BID

medium dose of CB-03-01, 0.5% applied twice a day

Group Type: EXPERIMENTAL

CB-03-01

Intervention Type: DRUG

Topical cream, applied twice a day

High-dose active, QD

high dose of CB-03-01, 1% applied once a day

Group Type: EXPERIMENTAL

CB-03-01

Intervention Type: DRUG

Topical cream, applied once a day

High-dose active, BID

high dose of CB-03-01, 1% applied twice a day

Group Type: EXPERIMENTAL

CB-03-01

Intervention Type: DRUG

Topical cream, applied twice a day

Vehicle, QD or BID

vehicle cream, applied once or twice a day

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Topical cream, applied once or twice a day

Interventions

CB-03-01

Topical cream, applied once a day

Intervention Type: DRUG

Vehicle

Topical cream, applied once or twice a day

Intervention Type: DRUG

CB-03-01

Topical cream, applied twice a day

Intervention Type: DRUG

Other Intervention Names

clascoterone; clascoterone

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intrepid Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R&D Cassiopea

Role: STUDY_DIRECTOR

Cassiopea S.p.A.

Locations

Dermatology Research Associates

Los Angeles, California, United States

Therapeutics Clinical Research

San Diego, California, United States

University Clinical Trials

San Diego, California, United States

International Clinical Research - US, LLC

Sanford, Florida, United States

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Indiana Clinical Trials Center

Plainfield, Indiana, United States

Marina I. Peredo, M.D., PC

Smithtown, New York, United States

Penn State Milton S. Hershey Medical Center - Dept. of Dermatology

Hershey, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

J & S Studies

College Station, Texas, United States

UT Houston Health Science Center

Houston, Texas, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

171-7151-201

Identifier Type: -

Identifier Source: org_study_id