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

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02682264

Run by

Cassiopea SpA

People needed

609

Starts

2016-03-09

Expected to finish

2018-08-31

Last updated by the study team

2020-11-17

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Gary M. Petrus, MD PA — Little Rock, Arkansas, United States
• Center for Dermatology and Laser Surgery — Sacramento, California, 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
• Memorial Research Medical Clinic dba / Orange County Research Center — Tustin, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Study Protocol, Inc. — Boynton Beach, Florida, United States
• Tory Sullivan, M.D., P.A. — North Miami Beach, Florida, United States
• Belleair Research Center — Pinellas Park, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• MOORE Clinical Research, Inc. — Tampa, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Arlington Dermatology — Arlington Heights, Illinois, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• Maryland Laser Skin and Vein Institute — Hunt Valley, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Sadick Research Group, LLC — New York, New York, United States
• Skin Specialty Dermatology — New York, New York, United States
• DermResearch Center of New York, Inc. — Stony Brook, New York, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.