SCC - Squamous Cell CarcinomaPhase 3NCT07311057
Investigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy
A Phase 3 study testing Formulated Topical Methylene Blue (0.5 mg/mL) and Wound Healing Gel in people with SCC - Squamous Cell Carcinoma and SCC - Squamous Cell Carcinoma of Skin, run by Daryoush Hamidi Alamdari, PhD at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCC - Squamous Cell Carcinoma, SCC - Squamous Cell Carcinoma of Skin, Inoperable Disease
- What is being tested?
- Formulated Topical Methylene Blue (0.5 mg/mL) and Wound Healing Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 20 Dec 2025to 20 Jan 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed diagnosis of squamous cell carcinoma (SCC)
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province
About this study
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:
Read more
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.
- Being tested
- Formulated Topical Methylene Blue (0.5 mg/mL), Wound Healing Gel
- Keywords
- Squamous cell carcinoma, Methylene blue, Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
Wound Healing GelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Formulated Methylene Blue Treatment Arm | Experimental | 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. Receives: Drug: Formulated Topical Methylene Blue (0.5 mg/mL); Drug: Wound Healing Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, every week for 4 weeks during treatment, and at 8 weeks post-treatment follow-up.
Secondary outcomes (1)
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.
Measured: At baseline (before treatment) and at completion of therapy (approximately 4 to 8 weeks after treatment initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Dec 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCC - Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daryoush Hamidi Alamdari, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daryoush Hamidi Alamdari, PhD, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311057
- Sponsor's protocol ID
- IR.MUMS.IRH.REC.1404.226
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy
- ClinicalTrials.gov ID
- NCT07311057
- Acronym / sponsor ID
- IR.MUMS.IRH.REC.1404.226
- Keywords
- Squamous cell carcinoma, Methylene blue, Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Daryoush Hamidi Alamdari, PhDUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formulated Methylene Blue Treatment Arm | Experimental | Drug: Formulated Topical Methylene Blue (0.5 mg/mL), Drug: Wound Healing GelParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically confirmed diagnosis of squamous cell carcinoma (SCC)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Drug | Formulated Methylene Blue Treatment Arm |
| Wound Healing GelFollowing 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. | Drug | Formulated Methylene Blue Treatment Arm |
Primary outcome
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.
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formulated Topical Methylene Blue (0.5 mg/mL) and Wound Healing Gel in people with SCC - Squamous Cell Carcinoma and SCC - Squamous Cell Carcinoma of Skin, run by Daryoush Hamidi Alamdari, PhD at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.