Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:24 AM
Study NCT ID:
NCT07311057
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-06
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Effect of Formulated Methylene Blue on Treatment of Squamous Cell Carcinoma Skin Cancer in Inoperable Patients and Not Suitable for Radiotherapy
Sponsor:
Daryoush Hamidi Alamdari, PhD
Organization:
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: