Study of Doxorubicin Microneedle Array for Treatment of Patients with Nodular Basal Cell Carcinoma

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1012907

• Contact name

  Edward Brennan

• Contact email

  ebrennan@medicuspharma.com

• Sponsor organisation

  Medicus Pharma, LTD

• Clinicaltrials.gov Identifier

  NCT06608238

• Research summary

  The D-MNA patch is an innovative treatment designed for nodular Basal Cell Carcinoma (BCC), a common form of skin cancer. It uses a small patch embedded with 400 tiny, dissolvable needles made of cellulose to deliver a cancer drug called doxorubicin directly into the tumor. This method allows the drug to be applied locally, minimizing its spread throughout the body and significantly reducing side effects compared to traditional systemic treatments, which use doses thousands of times higher. Doxorubicin is a well-established chemotherapy drug used to treat various cancers, and although its exact mechanism isn’t fully understood, it’s known to interfere with DNA in cancer cells, leading to their destruction. When delivered directly into the skin lesion, it’s expected to work similarly but with enhanced local effects, including tumor breakdown, inflammation, and activation of the immune system.
  The goal of developing the D-MNA patch is to offer a more effective and targeted non-surgical option for treating BCC. In a clinical study, around 90 patients will be randomly assigned to one of three groups: receiving either a high-dose (200 mcg) or low-dose (100 mcg) doxorubicin patch, or a placebo patch with no drug. Each patient will receive three treatments over two weeks, followed by surgical removal of the treated lesion and additional follow-up visits to monitor outcomes and safety. This study aims to evaluate how well the patch works and how safe it is, potentially paving the way for a new, less invasive treatment option for skin cancer.

• REC name

  Wales REC 1

• REC reference

  25/WA/0293

• Date of REC Opinion

  12 Nov 2025

• REC opinion

  Further Information Favourable Opinion