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

Phase 3Enrolling By InvitationNCT07311070

Daryoush Hamidi Alamdari, PhD20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Basal Cell Carcinoma (BCC)Inoperable Disease

Interventions

Formulated Topical Methylene Blue (0.5 mg/mL)DRUG

Participants will receive a topical formulation of methylene blue at a concentration of 0.5 mg/mL, applied directly to the basal cell carcinoma (BCC) lesions of the morpheaform, infiltrative, or noduloulcerative type. 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.

Wound Healing GelDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histopathologically confirmed diagnosis of morpheaform, infiltrative, or noduloulcerative basal cell carcinoma (BCC) * 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: * Superficial or nodular subtype of basal cell carcinoma * 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

Outcomes

Primary Outcomes

Rate of Wound Healing and Tumor Regression in Inoperable Basal Cell Carcinoma Treated with Topical Formulated Methylene Blue

The primary outcome of this study is to evaluate the efficacy of topical formulated methylene blue (0.5 mg/mL) in promoting wound healing and reducing tumor size in patients with inoperable or radiotherapy-resistant basal cell carcinoma (BCC) of morpheaform, infiltrative, and noduloulcerative subtypes. The assessment includes measurement of wound area and depth using standardized digital photography and calibrated sterile metal measurers. Images will be analyzed with the HealUp software to determine the rate of epithelialization and reduction in lesion size. The degree of tissue regeneration and clinical response will be documented before treatment and at defined follow-up intervals.

Time frame: Baseline, every week for 4 weeks during treatment, and at 8 weeks post-treatment follow-up.

Secondary Outcomes

Changes in Inflammatory and Biochemical Markers Before and After Treatment with Topical Formulated Methylene Blue

The secondary outcome is to assess the variation in systemic inflammatory and biochemical parameters, including C-reactive protein (CRP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST), measured before initiation of treatment and after complete wound healing. These biomarkers will be evaluated to determine the systemic safety profile and potential anti-inflammatory effects of topical formulated methylene blue. Blood samples will be analyzed in the central laboratory of Imam Reza Hospital using standard clinical chemistry assays.

Time frame: At baseline (before treatment) and at completion of therapy (approximately 4 to 8 weeks after treatment initiation).