SM-020 Gel for Seborrheic Keratosis

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: DermBiont, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a special gel called SM-020 to see if it can safely and effectively treat Seborrheic Keratosis, a common skin condition. Patients will apply the gel regularly for a few weeks. The goal is to see if the gel can reduce or eliminate the skin growths.

Eligibility Criteria

This trial is for adults with Seborrheic Keratosis who have at least 5 affected areas not on eyelids or covered by hair. Participants must understand and sign consent forms, be free of certain diseases, agree to follow study instructions, and attend all visits. Pregnant women or those not using birth control are excluded.

Inclusion Criteria

The size of the thing we're looking at must be bigger than 5mm but not bigger than 15mm.

Must be able to comprehend and willing to sign an informed consent form (ICF)

Must complete a signed Health Information Portability and Accountability Act (HIPAA) authorization form

+12 more

Exclusion Criteria

I have multiple sudden skin growths.

My skin lesions are unusual or growing quickly.

I am not pregnant, breastfeeding, or if capable of becoming pregnant, I agree to use birth control during the study.

+9 more

Participant Groups

The trial tests the safety and effectiveness of SM-020 gel (1%) compared to a placebo gel in treating Seborrheic Keratosis. It's randomized and double-blind, meaning neither participants nor researchers know who gets which treatment. The gel is applied twice daily for four weeks with a follow-up period of twelve weeks.

2Treatment groups

Active Control

Placebo Group

Group I: SM-020 gel 1.0%Active Control1 Intervention

SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.

Group II: Vehicle gelPlacebo Group1 Intervention

Vehicle gel will be applied topically. Subjects will be treated with twice daily application to 5 to 10 SKTLs for approximately 28 days.