An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Drug: CB-03-01 cream, 1%
- Registration Number
- NCT02682264
- Lead Sponsor
- Cassiopea SpA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 609
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CB-03-01 cream, 1% CB-03-01 cream, 1% 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events up to 52 weeks Number of participants with any local and systemic treatment emergent AEs (TEAEs)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Maryland Laser Skin and Vein Institute
🇺🇸Hunt Valley, Maryland, United States
Site 4812
🇵🇱Wrocław, Poland
Site 4822
🇵🇱Czestochowa, Poland
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
🇺🇸San Diego, California, United States
Dermatology Associates
🇺🇸Seattle, Washington, United States
Site 3808
🇺🇦Kharkiv, Ukraine
Site 3804
🇺🇦Kharkiv, Ukraine
Site 3809
🇺🇦Zaporizhzhya, Ukraine
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Site 9912
🇬🇪Tbilisi, Georgia
Site 4030
🇷🇴Sibiu, Romania
Site 4034
🇷🇴Sector 2, Bucharest, Romania
Site 4029
🇷🇴Sector 6, Bucharest, Romania
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Site 4820
🇵🇱Łódź, Poland
Site 4031
🇷🇴Sector 3, Bucharest, Romania
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Clinical Research Associates of Tidewater, Inc.
🇺🇸Norfolk, Virginia, United States
Site 8138
🇷🇸Belgrade, Serbia
Site 8137
🇷🇸Belgrade, Serbia
Site 8136
🇷🇸Novi Sad, Serbia
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Site 3524
🇧🇬Sofia, Bulgaria
Site 4037
🇷🇴Iaşi, Romania
Site 4823
🇵🇱Osielsko, Poland
Site 4813
🇵🇱Szczecin, Poland
Belleair Research Center
🇺🇸Pinellas Park, Florida, United States
DermResearch Center of New York, Inc.
🇺🇸Stony Brook, New York, United States
Westlake Dermatology Clinical Research Center
🇺🇸Austin, Texas, United States
Site 9913
🇬🇪Tbilisi, Georgia
Site 4035
🇷🇴Bucharest, Romania
Sadick Research Group, LLC
🇺🇸New York, New York, United States
Site 4033
🇷🇴Sector 2, Bucharest, Romania
Memorial Research Medical Clinic dba / Orange County Research Center
🇺🇸Tustin, California, United States
Tory Sullivan, M.D., P.A.
🇺🇸North Miami Beach, Florida, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Arlington Dermatology
🇺🇸Arlington Heights, Illinois, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
Greenville Dermatology, LLC
🇺🇸Greenville, South Carolina, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Site 3521
🇧🇬Plovdiv, Bulgaria
Site 3526
🇧🇬Sofia, Bulgaria
Site 9911
🇬🇪Tbilisi, Georgia
4819
🇵🇱Bydgoszcz, Poland
Site 4811
🇵🇱Dąbrówka, Poland
Site 4814
🇵🇱Białystok, Poland
4815
🇵🇱Katowice, Poland
Site 4028
🇷🇴Târgovişte, Jud. Dambovita, Romania
Site 3802
🇺🇦Dnipro, Ukraine
Gary M. Petrus, MD PA
🇺🇸Little Rock, Arkansas, United States
The Pennsylvania State University and the Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
3520
🇧🇬Sofia, Bulgaria
Southern California Dermatology
🇺🇸Santa Ana, California, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Study Protocol, Inc.
🇺🇸Boynton Beach, Florida, United States
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Site 3519
🇧🇬Sofia, Bulgaria
Site 3522
🇧🇬Varna, Bulgaria
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Center for Dermatology and Laser Surgery
🇺🇸Sacramento, California, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
MOORE Clinical Research, Inc.
🇺🇸Tampa, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Site 4818
🇵🇱Warszawa, Poland
Site 4821
🇵🇱Kraków, Poland