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

Daryoush Hamidi Alamdari, PhD

Status and phase: Invitation-only; Phase 3

Conditions: SCC - Squamous Cell Carcinoma of Skin; SCC - Squamous Cell Carcinoma; Inoperable Disease

Treatments: Drug: Wound Healing Gel; Drug: Formulated Topical Methylene Blue (0.5 mg/mL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07311057

IR.MUMS.IRH.REC.1404.226

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically confirmed diagnosis of squamous cell carcinoma (SCC)
• Provision of written informed consent to participate in the study
• Lack of willingness or eligibility for surgical excision or radiotherapy, or contraindication to intralesional medical treatments such as interferon-alpha or 5-fluorouracil (5-FU)
• Age ≥ 18 years
• Lesion size < 2 cm in diameter
• Presence of multiple lesions

Exclusion criteria

• Withdrawal of consent at any stage of the study
• Pregnancy or breastfeeding
• History of severe adverse reactions to medications
• Inability or unwillingness to attend follow-up visits
• History of cardiovascular disease
• History of thromboembolic disorders
• Prior radiotherapy to the affected area
• History of chronic arsenic exposure
• Immunodeficiency
• Presence of severe systemic illness
• Known allergy or hypersensitivity to methylene blue
• History of bleeding disorders or abnormal coagulation
• Severe inflammatory or dermatologic conditions in the treatment area
• Failure to complete the full course of treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Formulated Methylene Blue Treatment Arm

Experimental group

Description:

Participants in this single-arm, open-label pilot study will receive topical methylene blue-based dressing for the management of advanced or inoperable squamous cell carcinoma (SCC) wounds. Wound area and depth will be evaluated weekly for four weeks using standardized digital photography (30 cm distance) and sterile metallic measurement tools. Images will be analyzed with HealUp software to quantify wound area and healing progression. The study aims to preliminarily assess the efficacy and safety of methylene blue in promoting wound healing among five patients with refractory SCC lesions who are not candidates for surgery or radiotherapy.

Treatment:

Drug: Formulated Topical Methylene Blue (0.5 mg/mL)

Drug: Wound Healing Gel