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

NCT01631474 | Completed Phase 2 Results

• 1 other identifier: 171-7151-201
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 13

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Inflammatory and Non-Inflammatory Lesion Counts - Week 8

  Baseline and Week 8

• Percent Change in Lesion Counts - Weeks 8 and 12

  Week 8 and Week 12

• IGA "Success" - Week 8

  Baseline and Week 8

• IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12

  Weeks 4, 8, and 12

Study Arms (5)

Low-dose active, BID

EXPERIMENTAL

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

Drug: CB-03-01

Medium-dose active, BID

EXPERIMENTAL

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

Drug: CB-03-01

High-dose active, QD

EXPERIMENTAL

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

Drug: CB-03-01

High-dose active, BID

EXPERIMENTAL

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

Drug: CB-03-01

Vehicle, QD or BID

PLACEBO COMPARATOR

vehicle cream, applied once or twice a day

Drug: Vehicle

Interventions

CB-03-01 DRUG

Topical cream, applied once a day

Also known as: clascoterone

High-dose active, QD

Vehicle DRUG

Topical cream, applied once or twice a day

Vehicle, QD or BID

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intrepid Therapeutics, Inc.: lead

Study Sites (13)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

University Clinical Trials

San Diego, California, 92123, United States

Location

International Clinical Research - US, LLC

Sanford, Florida, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Marina I. Peredo, M.D., PC

Smithtown, New York, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, United States

Location

J & S Studies

College Station, Texas, 77845, United States

Location

UT Houston Health Science Center

Houston, Texas, 77030, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Cassiopea R&D
• Organization: Cassiopea, SpA

r&d@cassiopea.com

+39 02 868 911 24

Study Officials

• R&D Cassiopea

  Cassiopea S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Locations

US (13)