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A Trial to Study the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers

NCT06409195 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-10

No results posted yet for this study

Summary

Open-Label study evaluating safety and efficacy of SM-020 Gel 1.0% in subjects with Seborrheic Keratoses and Non-Melanoma Skin Cancers (i.e. Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ). Subjects will be enrolled into 1 of 5 cohorts. Each cohort will enroll approximately 5-10 subjects with at least 1 eligible lesion to be treated. A maximum of 5 lesions may be enrolled per subject. Treatment for all subjects and all lesions will be twice daily for approximately 28 days. Post treatment, residual lesions may be excised per standard of care for histological evaluation. The duration of the study is estimated to be approximately up to 12 weeks from the beginning of the Screening period until the last subject's last visit.

Conditions

Interventions

DRUG

SM-020 1% Gel

SM-020 gel 1.0% will be applied topically. Subjects will be treated with twice daily application to at least 1 and up to 5 Target Lesions (TLs) for 28 days.

Sponsors & Collaborators

  • DermBiont, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06409195 on ClinicalTrials.gov