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

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cassiopea SpA

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