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A Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratosis

NCT06108024 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Seborrheic Keratosis

Interventions

DRUG

SM-020 gel 1.0%

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.

DRUG

Vehicle gel

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

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2024-09-15
Completion
2024-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06108024 on ClinicalTrials.gov