Phase 3
Completed N=607
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
Source: ClinicalTrials.gov NCT02682264 ↗Enrolled (actual)
607
Serious AEs
1.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events — 58; 52 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events |
58; 52 | — |
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
Data sourced from ClinicalTrials.gov (NCT02682264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.