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

Acne Vulgaris Clinical Trial

Official title:

An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682264
• Other study ID #: CB-03-01/27
• Status: Completed
• Phase: Phase 3
• Start date: March 9, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2020
• Source: Cassiopea SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was a multicenter, open label, long-term extension study for CB-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26]. Participants applies the active medication (CB-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator AND desired by the participant, truncal acne for nine additional months of treatment. Thus, overall participants were exposed to CB-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the Phase 3 pivotal study and an additional nine months in this long-term safety study).

Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk).

Participants were rolled over from the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CB-03-01 cream, 1%
Cortexolone 17a-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.

Locations

Country	Name	City	State
Bulgaria	Site 3521	Plovdiv
Bulgaria	3520	Sofia
Bulgaria	Site 3519	Sofia
Bulgaria	Site 3524	Sofia
Bulgaria	Site 3526	Sofia
Bulgaria	Site 3522	Varna
Georgia	Site 9911	Tbilisi
Georgia	Site 9912	Tbilisi
Georgia	Site 9913	Tbilisi
Poland	Site 4814	Bialystok
Poland	4819	Bydgoszcz
Poland	Site 4822	Czestochowa
Poland	Site 4811	Dabrówka
Poland	4815	Katowice
Poland	Site 4821	Kraków
Poland	Site 4820	Lódz
Poland	Site 4823	Osielsko
Poland	Site 4813	Szczecin
Poland	Site 4818	Warszawa
Poland	Site 4812	Wroclaw
Romania	Site 4035	Bucharest
Romania	Site 4037	Iasi
Romania	Site 4033	Sector 2	Bucharest
Romania	Site 4034	Sector 2	Bucharest
Romania	Site 4031	Sector 3	Bucharest
Romania	Site 4029	Sector 6	Bucharest
Romania	Site 4030	Sibiu
Romania	Site 4028	Târgoviste	Jud. Dambovita
Serbia	Site 8137	Belgrade
Serbia	Site 8138	Belgrade
Serbia	Site 8136	Novi Sad
Ukraine	Site 3802	Dnipro
Ukraine	Site 3804	Kharkiv
Ukraine	Site 3808	Kharkiv
Ukraine	Site 3809	Zaporizhzhya
United States	Arlington Dermatology	Arlington Heights	Illinois
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Study Protocol, Inc.	Boynton Beach	Florida
United States	Shideler Clinical Research Center	Carmel	Indiana
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	Greenville Dermatology, LLC	Greenville	South Carolina
United States	The Pennsylvania State University and the Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Gary M. Petrus, MD PA	Little Rock	Arkansas
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Sadick Research Group, LLC	New York	New York
United States	Skin Specialty Dermatology	New York	New York
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Clinical Research Associates of Tidewater, Inc.	Norfolk	Virginia
United States	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Belleair Research Center	Pinellas Park	Florida
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Rady Childrens Hospital, Pediatric and Adolescent Dermatology	San Diego	California
United States	Southern California Dermatology	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Dermatology Associates	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	DermResearch Center of New York, Inc.	Stony Brook	New York
United States	MOORE Clinical Research, Inc.	Tampa	Florida
United States	Memorial Research Medical Clinic dba / Orange County Research Center	Tustin	California
United States	Omega Medical Research	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Cassiopea SpA

Countries where clinical trial is conducted

United States,  Bulgaria,  Georgia,  Poland,  Romania,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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