RecruitingPhase 2NCT06409195

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

Open-Label Study of the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic Keratoses and Non-Melanoma Skin Cancers (Basal Cell Carcinoma and Squamous Cell Carcinoma In Situ)

Sponsor

DermBiont, Inc.

Enrollment

50 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Melanoma Skin Cancers

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests SM-020 Gel 1.0%, a topical (skin-applied) treatment, for people with certain non-melanoma skin conditions including seborrheic keratosis, basal cell skin cancer, and squamous cell carcinoma in situ. Researchers are studying its safety and effectiveness applied directly to skin lesions. **You may be eligible if...** - You are at least 18 years old - You have a biopsy-confirmed skin condition including seborrheic keratosis, basal cell skin cancer (superficial, nodular, or infiltrating), or squamous cell carcinoma in situ - You are able and willing to sign consent and health privacy forms **You may NOT be eligible if...** - Your skin cancer has spread or requires systemic treatment - You have a serious skin condition or allergy that would interfere with topical treatment - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSM-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.

Locations(1)

Dermatology, Laser and Vein Specialist

Charlotte, North Carolina, United States

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NCT06409195