Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07311070

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Advanced Basal Cell Carcinoma (BCC) Carcinoma Carcinoma, Basal Cell Infiltrative Basal Cell Carcinoma Inoperable Disease Morpheaform Basal Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Noduloulcerative Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mashhad University of Medical Sciences

Mashhad, Razavi Khorasan Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Gel

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.

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Daryoush Hamidi Alamdari, PhD

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.