NCT07311057

Investigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Daryoush Hamidi Alamdari, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether formulated methylene blue can safely and effectively treat advanced or inoperable Squamous Cell Carcinoma (SCC), 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 SCC? 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.

Conditions

• SCC - Squamous Cell Carcinoma
• SCC - Squamous Cell Carcinoma of Skin
• Inoperable Disease

Interventions

Type	Name	Description
DRUG	Formulated Topical Methylene Blue (0.5 mg/mL)	Participants will receive a topical formulation of methylene blue at a concentration of 0.5 mg/mL, applied directly to the squamous cell carcinoma (SCC) lesions. The formulation will be administered every two days for a period of one month. The topical preparation is designed with a standard cream base containing carrier oils and lipids to enhance penetration into deeper skin layers and facilitate the delivery of the active compound. Additional excipients include zinc oxide and copper to support wound healing. Clinical photographs of the lesions will be taken at each application to monitor treatment progress.
DRUG	Wound Healing Gel	Following completion of the methylene blue treatment, a wound healing gel will be applied to the treated lesions. This gel, which contains platelet-rich fibrin and other supportive compounds, has demonstrated efficacy in removing necrotic tissue and promoting tissue regeneration. The gel will be used until complete wound closure is achieved.

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-01-20
• Completion: 2026-01-20
• First posted: 2025-12-30
• Last updated: 2026-01-06

Locations

1 site across 1 country: Iran