Treatment of Basal Cell Carcinoma (BCC) of the Skin, of the Morpheiform, Infiltrative, and Noduloulcerative Types in Inoperable Patients and Not Suitable for Radiotherapy Using Formulated Methylene Blue

The goal of this clinical trial is to evaluate whether formulated methylene blue can safely and effectively treat advanced or inoperable basal cell carcinoma (BCC), a common type of skin cancer. This condition mainly affects adults and often occurs on the head or neck. Some patients cannot undergo surgery or radiotherapy due to tumor invasion, recurrence, or health limitations. The main questions this study aims to answer are: Can formulated methylene blue reduce tumor size and promote healing in patients with advanced BCC? Is this treatment safe and well-tolerated? There is no comparison group in this study. Researchers will assess each patient's response before and after the treatment. Participants will: Receive topical methylene blue solution or ointment applied to the affected skin every two days for one month. Undergo clinical and photographic evaluation before, during, and after treatment. Use a proven wound-healing gel following methylene blue therapy to assist tissue recovery. Blood tests and clinical follow-up will be conducted for six months to monitor safety and long-term effects. The study aims to provide new evidence for a non-invasive and low-cost therapeutic option for patients who cannot receive standard treatments.

NCT Number	NCT07311070
Lead Sponsor	Daryoush Hamidi Alamdari, PhD
Conditions	Advanced Basal Cell Carcinoma (BCC), Inoperable Disease, Morpheaform Basal Cell Carcinoma, Noduloulcerative Basal Cell Carcinoma, Infiltrative Basal Cell Carcinoma
Enrollment	20 participants
Start Date	2025-10-21
Primary Completion	2026-01-20 (estimated)
Study Completion	2026-01-20 (estimated)
Updated on ClinicalTrials.gov	2026-01-06