Study on the Safety and Effectiveness of SM-020 Gel 1.0% for Treating Seborrheic Keratoses and Non-Melanoma Skin Cancers

Sponsor: DermBiont, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06409195

Provider View

This clinical trial is testing a new gel treatment, SM-020 Gel 1.0%, to see if it is safe and effective for people with seborrheic keratoses and certain types of non-melanoma skin cancers. Participants will apply the gel twice daily for about 28 days.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of SM-020 Gel 1.0% in treating seborrheic keratoses and non-melanoma skin cancers, such as basal cell carcinoma and squamous cell carcinoma in situ. Participants will be divided into five groups, with each group having 5-10 participants. Each participant can have up to five skin lesions treated with the gel. The treatment involves applying the gel twice a day for approximately 28 days. After treatment, any remaining lesions may be surgically removed for further examination. The entire study is expected to last up to 12 weeks, from the initial screening to the final follow-up visit.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must sign a form allowing the use of their health information.
  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of seborrheic keratosis or certain types of non-melanoma skin cancers.
  • Must have between 1 and 5 eligible skin lesions, each between 0.5-2.0 cm in size.
  • Skin cancers must be new (not previously treated) and located on specific body areas like the scalp, face, trunk, or limbs.
  • Seborrheic keratoses must meet specific criteria and be located on certain body areas.
  • Must not have any health conditions that could interfere with the study or pose a risk.
  • Must be willing to follow study instructions and attend all visits.
  • Must be able to apply the treatment to all lesions.
  • Must agree to have all lesions surgically removed at the end of the study.

Exclusion Criteria

  • Pregnant or breastfeeding women, or women who do not agree to use birth control during the study.
  • Lesions that are unusual or growing quickly.
  • Having multiple new seborrheic keratoses.
  • Current systemic cancer.
  • History of certain blood disorders.
  • Recent use of specific medications or treatments that could interfere with the study.
  • Recent use of certain topical treatments on or near the lesions.
  • Recent skin cancer, sunburn, or body art near the lesions.
  • Allergy to any ingredients in the gel.
  • Current skin conditions that could interfere with the study.
  • Participation in another drug trial within 30 days before this study.
  • History of certain types of scarring.

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