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Blue dye gel shows promise for treating inoperable skin cancer

NCT ID NCT07311057

Disease control Sponsor: Daryoush Hamidi Alamdari, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special blue dye gel (methylene blue) can safely shrink skin cancer tumors and help wounds heal in people who cannot have surgery or radiation. About 20 adults with advanced squamous cell carcinoma will apply the gel every two days for a month, followed by a healing gel. Researchers will track tumor size and safety for six months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

carcinoma skin squamous cell carcinoma squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inoperable disease SCC - squamous cell carcinoma SCC - squamous cell carcinoma of skin

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Mashhad University of Medical Sciences

    Mashhad, Razavi Khorasan Province, Iran

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