A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

NCT02608450 | Completed Phase 3 Results

• 1 other identifier: CB-03-01/25
• Study Type: interventional
• Target: 708
• Locations: 3 countries
• Sites: 54

Brief Summary

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Conditions

Acne Vulgaris

Keywords

acne; clascoterone; anti-androgen

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)

  Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.

  Week 12

• Change From Baseline in Non-inflammatory Lesion Counts

  Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.

  Baseline and Week 12

• Change From Baseline in Inflammatory Lesion Counts

  Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.

  Baseline and Week 12

Secondary Outcomes (4)

• Change From Baseline in Total Lesion Counts

  Baseline and Week 12

• Percent Change From Baseline in Total Lesion Counts

  Baseline and Week 12

• Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts

  Baseline and Week 12

• Percent Change From Baseline in Inflammatory Lesion (IL) Counts

  Baseline and Week 12

Other Outcomes (1)

• Local Site Reactions

  Baseline, Weeks 4, 8, and 12

Study Arms (2)

CB-03-01 cream

EXPERIMENTAL

CB-03-01 cream, 1% applied twice daily for 12 weeks

Drug: CB-03-01 cream, 1%

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream applied twice daily for 12 weeks

Drug: Vehicle cream

Interventions

CB-03-01 cream, 1% DRUG

CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.

Also known as: cortexolone 17α-propionate, clascoterone (USAN, INN)

CB-03-01 cream

Vehicle cream DRUG

Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.

Vehicle cream

Eligibility Criteria

• Age: 9 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, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
• Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
• Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) \[0 (clear) to 4 (severe) scale\].
• Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
• Subject and parent/guardian (if applicable) are 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 (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit 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 has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
• Subject has greater than two (2) facial nodules.
• Subject has nodulocystic acne.
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
• Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
• Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
• 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 prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
• Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Sponsors & Collaborators

• Cassiopea SpA: lead

Study Sites (54)

Gary M. Petrus, MD PA

Little Rock, Arkansas, 72205, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, 90036, United States

Location

San Diego Sports Medicine and Family Health Center

San Diego, California, 92120, United States

Location

Rady Childrens Hospital, Pediatric and Adolescent Dermatology

San Diego, California, 92123, United States

Location

Southern California Dermatology

Santa Ana, California, 92701, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Memorial Research Medical Clinic dba / Orange County Research Center

Tustin, California, 92780, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Site 0190

Boca Raton, Florida, 33434, United States

Location

Study Protocol, Inc.

Boynton Beach, Florida, 33437, United States

Location

Site 0196

Miami, Florida, 33125, United States

Location

Site 0197

Miami, Florida, 33126, United States

Location

Site 0198

Miami, Florida, 33135, United States

Location

Site 0199

Miami, Florida, 33145, United States

Location

Site 0191

Miami, Florida, 33172, United States

Location

Site 0192

Miami, Florida, 33172, United States

Location

Site 0195

Miami, Florida, 33176, United States

Location

Tory Sullivan, M.D., P.A.

North Miami Beach, Florida, 33162, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Site 0152

Carmel, Indiana, 46032, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York, 10549, United States

Location

DermResearch Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

The Pennsylvania State University and the Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Greenville Dermatology, LLC

Greenville, South Carolina, 29607, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Westlake Dermatology Clinical Research Center

Austin, Texas, 78746, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Clinical Research Associates of Tidewater, Inc.

Norfolk, Virginia, 23507, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Site 9911

Tbilisi, 0159, Georgia

Location

Site 9913

Tbilisi, 0179, Georgia

Location

Site 9912

Tbilisi, 0194, Georgia

Location

Site 3802

Dnipro, 49000, Ukraine

Location

Site 3804

Kharkiv, 31038, Ukraine

Location

3808

Kharkiv, 61002, Ukraine

Location

Site 3801

Kyiv, 01601, Ukraine

Location

3807

Lviv, 79014, Ukraine

Location

Site 3803

Ternopil, 46006, Ukraine

Location

Site 3809

Zaporizhzhya, 69063, Ukraine

Location

Related Publications (3)

• Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.

  PMID: 36745367 DERIVED

• Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.

  PMID: 34607697 DERIVED

• Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

  PMID: 32320027 DERIVED

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 18, 2015
• Study Start: January 21, 2016
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Locations

UA (7); US (44); GE (3)