Evaluating D-MNA for treating 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

This study is testing if two different strengths of a new treatment called D-MNA can safely help adults with nodular basal cell carcinoma better than a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: SkinJect, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 6 sites (Fresno, California and 5 other locations)
• Trial ID: NCT06608238 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of two different strengths of D-MNA compared to a placebo in adult patients with nodular basal cell carcinoma (nBCC). It is a double-blind, randomized, placebo-controlled trial where approximately 60 subjects will receive intradermal injections of D-MNA or placebo once weekly for three weeks. Following the treatment period, the target lesion will be excised for evaluation. An interim analysis will be conducted after a subset of subjects completes the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histologically confirmed, untreated nBCC lesion suitable for excision.

Not a fit: Patients with nBCC located on the face, scalp, or previously treated areas may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with nodular basal cell carcinoma.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific use of D-MNA in this context is novel.

Eligibility criteria

Inclusion Criteria:

1. Male or non-pregnant female ≥ 18 years of age.
2. Clinical diagnosis of a primary, previously untreated, histologically confirmed nodular Basal Cell Carcinoma (nBCC) lesion suitable for excision (at end of the study) with a minimum diameter of 0.5 cm and with a maximum longest diameter of 1.3 cm at the time of biopsy and Visit 2/Baseline.
3. Willing to refrain from exposure to excessive direct sunlight or ultraviolet light and to avoid the use of tanning beds for the duration of the study.
4. Willing and able to receive the test article treatments, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion Criteria:

1. Pregnant, lactating, or planning to become pregnant.
2. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
3. History of treated nBCC lesion recurrence or basal cell nevus syndrome.
4. Immunocompromised, based on medical condition (e.g., human immunodeficiency virus), medication use, or other factors.
5. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
6. Used systemic chemotherapeutic agents within the 12 months prior to Visit 2/Baseline.
7. Clinical laboratory results at Visit 1/Screening within the following ranges: (a) granulocytes \< 2,000/mm3, (b) platelets \<50,000/mm3, (c) serum creatinine greater than 2 times the upper limit of normal (ULN), (d) aspartate aminotransferase, alkaline aminotransferase, lactate dehydrogenase, or alkaline phosphatase greater than 3 times the ULN.
8. History of sensitivity to any of the ingredients in the test articles .

12. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

9. Used the following topical agents within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy: aminolevulinic acid, 5-fluorouracil, diclofenac, ingenol mebutate, tirbanibulin, or imiquimod.

10. Has been treated with liquid nitrogen, surgical excision or curettage within 2 cm of the Target Lesion within 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.

11. Currently enrolled in an investigational drug, biologic, or device study. 12. Used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to enrollment into the study.

13. Unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity)

Where this trial is running

Fresno, California and 5 other locations

• Site #4 — Fresno, California, United States (Recruiting)
• Site #6 — San Diego, California, United States (Not_yet_recruiting)
• Site #1 — Rolling Meadows, Illinois, United States (Recruiting)
• Site #5 — Mandeville, Louisiana, United States (Recruiting)
• Site #3 — Highlands, New Jersey, United States (Recruiting)
• Site#2 — Knoxville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Marietta P Radona, MD

Conditions Nodular Basal Cell Carcinoma