Study on the Safety and Effectiveness of D-MNA for Treating Nodular Basal Cell Skin Cancer in Adults

Sponsor: SkinJect, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06608238

Provider View

This clinical trial is testing two different strengths of a new drug, D-MNA, to see if it is safe and effective in treating nodular basal cell skin cancer compared to a placebo, which looks like the drug but has no active ingredients.

Patient Parameters

Program Overview

The study aims to find out how safe and effective D-MNA is when given as an injection into the skin for treating nodular basal cell carcinoma (nBCC), a type of skin cancer. About 60 participants will be randomly assigned to receive either the D-MNA injection or a placebo once a week for three weeks. After two weeks, the treated skin area will be surgically removed for examination. An interim analysis will be conducted after 26-30 participants have completed the treatment and surgery.

Description

This study is a double-blind, randomized, placebo-controlled trial, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo. The trial involves giving D-MNA as an injection directly into the skin where the cancer is located. Participants will receive this treatment once a week for three weeks. After two weeks, the cancerous area will be surgically removed to see how well the treatment worked. An interim analysis will be done after a certain number of participants have completed the treatment to assess the results so far.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and not pregnant.
  • Have a confirmed diagnosis of nodular basal cell carcinoma (nBCC) that has not been treated before and is suitable for surgical removal at the end of the study.
  • The cancerous area must be between 0.5 cm and 1.3 cm in size.
  • Must agree to avoid excessive sun exposure and not use tanning beds during the study.
  • Must be willing to receive the treatment and attend all follow-up visits.

Exclusion Criteria

  • Pregnant, breastfeeding, or planning to become pregnant.
  • Cancer located on the face, scalp, fingers, or areas with scars or previous radiation treatment.
  • History of recurring nBCC or a condition called basal cell nevus syndrome.
  • Have a weakened immune system due to medical conditions or medications.
  • Have another active cancer, except for certain non-threatening types.
  • Have used chemotherapy drugs in the past year.
  • Have certain abnormal blood test results.
  • Allergic to any ingredients in the study treatments.
  • Have used certain skin treatments near the cancer area within four weeks before starting the study.
  • Have had recent treatments like liquid nitrogen or surgery near the cancer area.
  • Currently participating in another clinical trial or have used investigational treatments recently.
  • Unlikely to follow the study requirements due to issues like alcohol or drug dependency.

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