An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

NCT02682264 | Completed Phase 3 Results

• 1 other identifier: CB-03-01/27
• Study Type: interventional
• Target: 609
• Locations: 7 countries
• Sites: 74

Brief Summary

The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

Conditions

Acne Vulgaris

Keywords

acne; clascoterone; anti-androgen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events

  Number of participants with any local and systemic treatment emergent AEs (TEAEs)

  up to 52 weeks

Study Arms (1)

CB-03-01 cream, 1%

EXPERIMENTAL

CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.

Drug: CB-03-01 cream, 1%

Interventions

CB-03-01 cream, 1% DRUG

Cortexolone 17α-propionate (USAN/INN: clascoterone) 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, 1%

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:

• Participant has successfully completed participation in one of the Phase 3 pivotal studies \[CB-03-01/25 and CB-03-01/26\].
• Participant agrees to use effective method of contraception throughout study, if applicable.
• Participant has provided written informed consent or assent.
• Participant is willing to comply with study instructions and return to the clinic for required visits.

You may not qualify if:

• Participant is pregnant, lactating, or is planning to become pregnant during the study.
• Participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy.
• Participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study.
• Participant plans to use any other investigational drug or device during participation in this study.
• Participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients.
• Participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study

Sponsors & Collaborators

• Cassiopea SpA: lead

Study Sites (74)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Gary M. Petrus, MD PA

Little Rock, Arkansas, 72205, United States

Location

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, 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

Study Protocol, Inc.

Boynton Beach, Florida, 33437, United States

Location

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

North Miami Beach, Florida, 33162, United States

Location

Belleair Research Center

Pinellas Park, Florida, 33781, 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

Arlington Dermatology

Arlington Heights, Illinois, 60005, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Kansas City Dermatology, PA

Overland Park, Kansas, 66215, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Sadick Research Group, LLC

New York, New York, 10075, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

DermResearch Center of New York, Inc.

Stony Brook, New York, 11790, 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

Clinical Partners, LLC

Johnston, Rhode Island, 02919, 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

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

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78229, 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 3521

Plovdiv, 4000, Bulgaria

Location

3520

Sofia, 1407, Bulgaria

Location

Site 3524

Sofia, 1407, Bulgaria

Location

Site 3519

Sofia, 1431, Bulgaria

Location

Site 3526

Sofia, 1618, Bulgaria

Location

Site 3522

Varna, 9010, Bulgaria

Location

Site 9912

Tbilisi, 0114, Georgia

Location

Site 9911

Tbilisi, 0159, Georgia

Location

Site 9913

Tbilisi, 9913, Georgia

Location

Site 4814

Bialystok, Poland

Location

4819

Bydgoszcz, Poland

Location

Site 4822

Częstochowa, Poland

Location

Site 4811

Dąbrówka, Poland

Location

4815

Katowice, Poland

Location

Site 4821

Krakow, Poland

Location

Site 4820

Lodz, Poland

Location

Site 4823

Osielsko, Poland

Location

Site 4813

Szczecin, Poland

Location

Site 4818

Warsaw, Poland

Location

Site 4812

Wroclaw, Poland

Location

Site 4033

Sector 2, Bucharest, 020125, Romania

Location

Site 4034

Sector 2, Bucharest, 020125, Romania

Location

Site 4031

Sector 3, Bucharest, 030303, Romania

Location

Site 4029

Sector 6, Bucharest, 062272, Romania

Location

Site 4028

Târgovişte, Jud. Dambovita, Romania

Location

Site 4035

Bucharest, Romania

Location

Site 4037

Iași, 700381, Romania

Location

Site 4030

Sibiu, Romania

Location

Site 8138

Belgrade, 11050, Serbia

Location

Site 8137

Belgrade, 8137, Serbia

Location

Site 8136

Novi Sad, 21000, Serbia

Location

Site 3802

Dnipro, 49000, Ukraine

Location

Site 3808

Kharkiv, 61002, Ukraine

Location

Site 3804

Kharkiv, 61038, Ukraine

Location

Site 3809

Zaporizhzhya, 69063, Ukraine

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 SpA

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 15, 2016
• Study Start: March 9, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (8); UA (4); BU (6); US (39); SE (3); GE (3); PL (11)