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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Formulated Topical Methylene Blue (0.5 mg/mL), Wound Healing Gel.
- Who it may be relevant to
- Registry conditions: Advanced Basal Cell Carcinoma (BCC), Inoperable Disease, Morpheaform Basal Cell Carcinoma, Noduloulcerative Basal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iran
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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 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. Additi - 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.
Primary outcome measures
- 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.]
Secondary outcome measures (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).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iran · 1 center
- Mashhad University of Medical Sciences — Mashhad
Identifiers
NCT: NCT07311070 · IR.MUMS.IRH.REC.1404.165