SkinJect Patch Shows Early Success in Phase 2 Study for Basal Cell Carcinoma

Medicus Pharma’s Phase 2 trial of its dissolvable microneedle patch for nodular basal cell carcinoma has expanded from 60 to 90 patients, with new sites added in the U.S. and Europe. Backed by over 60% clinical clearance and no serious side effects, the company seeks FDA engagement and global validation for this innovative, non-invasive treatment.

Medicus Pharma has announced expansion of its ongoing SKNJCT-003 Phase 2 trial evaluating a novel microneedle patch therapy for nodular basal cell carcinoma (BCC). The investigational therapy, D-MNA, delivers a chemotherapeutic agent directly into the tumor via a dissolvable skin patch — and early signs suggest it may be a game-changer.

The expansion, recently approved by the Institutional Review Board (IRB), comes on the heels of encouraging interim data showing more than 60% of enrolled patients achieved complete clinical clearance of their lesions.

“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate,” stated Dr. Raza Bokhari, Executive Chairman & CEO of Medicus Pharma. “With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-pacific region, we are making promising progress in securing global validation of our novel, non-invasive treatment for BCC.”

Medicus Pharma’s solution is SkinJect™: a patented, needle-free patch embedded with dissolvable microneedles containing D-MNA, a chemotherapeutic compound. Once applied, the patch delivers the drug directly into the lesion, bypassing systemic exposure and the need for surgical intervention.

The SKNJCT-003 study is a randomized, double-blind, placebo-controlled, multi-center trial. Participants are randomly assigned to receive either a placebo (P-MNA), a low dose (100μg), or a high dose (200μg) of D-MNA. The high-dose group reflects the maximum tested in the company’s Phase 1 trial, which concluded in 2021 and demonstrated strong safety with no dose-limiting toxicities or serious adverse events among the 13 participants.

Promising Early Results

Interim results from March 2025 offer early optimism. Not only did over 60% of patients experience full clinical clearance of their BCC lesions, but the treatment was also well tolerated across both dosing groups. There were no significant abnormalities in labs, vital signs, ECGs, or physical exams — and no systemic side effects were observed.

A New Direction for BCC Treatment

Basal cell carcinoma is the most common form of skin cancer, with millions of new cases diagnosed each year. While it rarely metastasizes, nodular BCC can be locally invasive, and treatment often involves surgical excision — a potentially scarring and anxiety-inducing procedure for patients.

Medicus Pharma is targeting a meeting with the U.S. FDA later this year to further define the regulatory pathway for D-MNA. If future trial results continue to reflect the preliminary data, the SkinJect patch may soon enter Phase 3 studies — and potentially become a paradigm-shifting treatment for BCC.