drugset / Trial / NCT05136144
Adaptive Design Study for Safety and Efficacy of Treatment Regimens With SM-020 in Subjects With Seborrheic Keratosis
NaSequentialOpen-labelTreatment
Summary
This is a first-in-humans adaptive design open label trial to explore the safety and efficacy of SM-020. Multiple dosing cohorts will be enrolled. The first cohort will have a two-week treatment period of twice daily applications followed by a four-week follow-up period. Based on the results at any time from the first and subsequent cohorts, additional cohorts will explore different dosing regimens.
Timeline
- Start
- 2021-10-19
- Primary completion
- 2024-05-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SM-020 | Unknown | 0.1 % | Topical |
| Subject | SM-020 | Unknown | 1 % | Topical |