Trial · Interventional
Enrolling by invitationPhase 3Registry dataInvestigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy
Overview
- Status
- Enrolling by invitation
- Phase
- Phase 3
- Enrollment
- 20 participants (estimated)
- Sponsor
- Daryoush Hamidi Alamdari, PhD · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Iran
- Start
- 20 Dec 2025
- Primary completion
- 20 Jan 2026 (estimated)
- Completion
- 20 Jan 2026 (estimated)
- First posted
- 30 Dec 2025
- Last update posted
- 6 Jan 2026
- Conditions
- SCC - Squamous Cell Carcinoma · SCC - Squamous Cell Carcinoma of Skin · Inoperable Disease
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Investigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy
NCT0731105720 Dec 2025 to est. 20 Jan 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Formulated Topical Methylene Blue (0.5 mg/mL)Drug
- Wound Healing GelDrug
Arms1
Experimental
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 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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Rate of Wound Healing and Tumor Regression in Inoperable squamous 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.
Registry description
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.
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).
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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