A Phase 3 interventional study of Formulated Topical Methylene Blue (0.5 mg/mL) and Wound Healing Gel in SCC - Squamous Cell Carcinoma, SCC - Squamous Cell Carcinoma of Skin and Inoperable Disease, sponsored by Daryoush Hamidi Alamdari, PhD. Enrolling by invitation at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Daryoush Hamidi Alamdari, PhD · Phase 3, Interventional, and Treatment
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.
627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Daryoush Hamidi Alamdari, PhD is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Formulated Topical Methylene Blue (0.5 mg/mL) · Drug: Wound Healing Gel
Participants will receive a topical formulation of methylene blue at a concentration of 0.5 mg/mL, applied directly to the squamous cell carcinoma (SCC) lesions. 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.
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.
Rate of Wound Healing and Tumor Regression in Inoperable squamous 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 squamous cell carcinoma (SCC). 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.
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).
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2026, 1 month after the start.
Of 21 phase 3 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 91. This study's planned 1 month is below that.
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Daryoush Hamidi Alamdari, PhD