Randomized Double-Blind Vehicle-Controlled Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis
DermBiont, Inc.
Summary
The objective of the trial is to evaluate the safety and efficacy of SM-020 gel 1.0% in subjects with Seborrheic Keratosis (SK) compared to vehicle gel. It is a randomized, double-blind, vehicle-controlled trial. Approximately 60 subjects will be enrolled. Subjects will apply their assigned investigational product twice daily for 4 consecutive weeks. Subjects will be followed for 12-weeks post final application for a total of approximately 16-weeks of required participation in the study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1. Must be able to comprehend and willing to sign an informed consent form (ICF). 2. Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of the subject's individually identifiable health information. 3. Must be at least 18 years of age. 4. Must have a minimum of 5 eligible facial, truncal, intertriginous, or extremity SKTLs. A maximum of 10 SKTLs will be targeted for treatment. An eligible SKTL must : 1.…