RecruitingPhase 2NCT06608238

The Purpose of This Study is to Evaluate the Safety and Efficacy of D-MNA in Adult Patients With Nodular Basal Cell Carcinoma

A Randomized, Double-Blinded, Placebo Controlled Trial to Evaluate the Safety and Efficacy of a Doxorubicin Microneedle Array (D-MNA) for the Treatment of Nodular Basal Cell Carcinoma in Adults


Sponsor

SkinJect, Inc.

Enrollment

60 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the study is to learn about the safety and how effective two different strengths of D-MNA compared to a placebo (a look-alike substance that contains no drug) in the treatment of nodular basal cell skin cancer


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new topical treatment called D-MNA for a common type of skin cancer called nodular basal cell carcinoma (a small, firm skin growth that is not melanoma). Researchers want to see if applying this treatment directly to the skin is safe and effective before the tumor is surgically removed. **You may be eligible if...** - You are 18 years or older (male or non-pregnant female) - You have been diagnosed with nodular basal cell carcinoma for the first time (never treated before) - The skin lesion is between 0.5 cm and 1.3 cm in size - You are willing to avoid excessive sun exposure and tanning beds during the study - You are able to attend all follow-up visits **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant - The skin cancer is located on the face, scalp, or fingers - You have previously received treatment for this lesion 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

DRUGD-MNA 200 mcg

D-MNA , (doxorubicin) patch, 200 mcg

DRUGD-MNA 100 mcg

D-MNA (doxorubicin) patch, 100 mcg

OTHERPlacebo

P-MNA patch, placebo


Locations(6)

Site #4

Fresno, California, United States

Site #6

San Diego, California, United States

Site #1

Rolling Meadows, Illinois, United States

Site #5

Mandeville, Louisiana, United States

Site #3

Highlands, New Jersey, United States

Site#2

Knoxville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06608238


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