CompletedPhase 2

Phase 2 Study Evaluating the Safety and Efficacy of Microneedle-mediated Delivery of Doxorubicin (D-MNA) in Patients With Nodular Basal Cell Carcinoma.

United States90 participantsStarted 2024-09-03

Plain-language summary

This Phase 2 study evaluates the safety and efficacy of microneedle array (MNA) alone and in combination with two dose levels of doxorubicin (100µg and 200µg) in patients with nodular basal cell carcinoma. Efficacy is assessed using both clinical (visual) and histological endpoints, which together provide a comprehensive evaluation of lesion response.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant female ≥ 18 years of age at time of consent.
✓. 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.

Exclusion criteria

✕. Pregnant, lactating, or planning to become pregnant.
✕. nBCC is located on the face, scalp, digits, mucosa, or skin that is scarred or previously treated with radiation.
✕. History of treated nBCC lesion recurrence or basal cell nevus syndrome.
✕. Active malignancy, excluding non-metastatic prostate cancer, other cutaneous basal or squamous cell carcinomas, and carcinoma of the cervix.
✕. Used topical immunomodulators within 2 cm of the Target Lesion within the 4 weeks prior to Visit 2/Baseline or after the confirmatory biopsy.
✕. 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.
✕. 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.

What they're measuring

Histological Clearance of Target Lesion

Timeframe: Day 29 or Day 57 following treatment, per protocol amendment.

Trial details

NCT IDNCT06608238

SponsorSkinJect, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-05

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