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

NCT ID: NCT07311070

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-21
• Study Completion Date: 2026-01-20

Brief Summary

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.

Conditions

Advanced Basal Cell Carcinoma (BCC); Inoperable Disease; Morpheaform Basal Cell Carcinoma; Noduloulcerative Basal Cell Carcinoma; Infiltrative Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formulated Methylene Blue Treatment Arm

Participants in this single-arm, open-label pilot study will receive topical methylene blue-based dressing for the management of advanced or inoperable basal cell carcinoma (BCC) wounds, including morpheaform, infiltrative, or noduloulcerative subtypes.

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 BCC lesions who are not candidates for surgery or radiotherapy.

Group Type: EXPERIMENTAL

Formulated Topical Methylene Blue (0.5 mg/mL)

Intervention Type: 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 Gel

Intervention Type: DRUG

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.

Interventions

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 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daryoush Hamidi Alamdari, PhD

OTHER

Sponsor Role: lead

Responsible Party

Daryoush Hamidi Alamdari, PhD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Countries

Iran

Other Identifiers

IR.MUMS.IRH.REC.1404.165

Identifier Type: -

Identifier Source: org_study_id