Clinical trial NCT02682264: An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: acne
clascoterone
anti-androgen
Lead sponsor: Cassiopea SpA
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 609
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Little Rock
country: United States
facility: Gary M. Petrus, MD PA
state: Arkansas
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital, Pediatric and Adolescent Dermatology
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Tustin
country: United States
facility: Memorial Research Medical Clinic dba / Orange County Research Center
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Boynton Beach
country: United States
facility: Study Protocol, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, M.D., P.A.
state: Florida
city: Pinellas Park
country: United States
facility: Belleair Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Arlington Heights
country: United States
facility: Arlington Dermatology
state: Illinois
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: New York
country: United States
facility: Sadick Research Group, LLC
state: New York
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc.
state: New York
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Hershey
country: United States
facility: The Pennsylvania State University and the Milton S. Hershey Medical Center
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Dermatology, LLC
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Plovdiv
country: Bulgaria
facility: Site 3521
city: Sofia
country: Bulgaria
facility: 3520
city: Sofia
country: Bulgaria
facility: Site 3524
city: Sofia
country: Bulgaria
facility: Site 3519
city: Sofia
country: Bulgaria
facility: Site 3526
city: Varna
country: Bulgaria
facility: Site 3522
city: Tbilisi
country: Georgia
facility: Site 9912
city: Tbilisi
country: Georgia
facility: Site 9911
city: Tbilisi
country: Georgia
facility: Site 9913
city: Białystok
country: Poland
facility: Site 4814
city: Bydgoszcz
country: Poland
facility: 4819
city: Czestochowa
country: Poland
facility: Site 4822
city: Dąbrówka
country: Poland
facility: Site 4811
city: Katowice
country: Poland
facility: 4815
city: Kraków
country: Poland
facility: Site 4821
city: Osielsko
country: Poland
facility: Site 4823
city: Szczecin
country: Poland
facility: Site 4813
city: Warszawa
country: Poland
facility: Site 4818
city: Wrocław
country: Poland
facility: Site 4812
city: Łódź
country: Poland
facility: Site 4820
city: Sector 2
country: Romania
facility: Site 4033
state: Bucharest
city: Sector 2
country: Romania
facility: Site 4034
state: Bucharest
city: Sector 3
country: Romania
facility: Site 4031
state: Bucharest
city: Sector 6
country: Romania
facility: Site 4029
state: Bucharest
city: Târgovişte
country: Romania
facility: Site 4028
state: Jud. Dambovita
city: Bucharest
country: Romania
facility: Site 4035
city: Iaşi
country: Romania
facility: Site 4037
city: Sibiu
country: Romania
facility: Site 4030
city: Belgrade
country: Serbia
facility: Site 8138
city: Belgrade
country: Serbia
facility: Site 8137
city: Novi Sad
country: Serbia
facility: Site 8136
city: Dnipro
country: Ukraine
facility: Site 3802
city: Kharkiv
country: Ukraine
facility: Site 3808
city: Kharkiv
country: Ukraine
facility: Site 3804
city: Zaporizhzhya
country: Ukraine
facility: Site 3809
Study officials:
affiliation: Cassiopea SpA
name: R&D Cassiopea
role: STUDY_DIRECTOR
References: