Determining the clinical effects of formulated methylene blue in reducing tumor size in basal cell carcinoma (BCC)
Design
Non-randomized phase 2-3 clinical trial on 20 patients
Settings and conduct
In this study, patients visit the skin clinic of Imam Reza Hospital and the treating physician selects and includes patients based on the inclusion and exclusion criteria.
Methylene blue 0.5mg/ml solution and formulated ointment are applied topically to the lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure is continued until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy is applied for another month.
Also, if the patient agrees, tissue sampling will be used for pathological evaluation. Patients will be followed up for 6 months.
The collected data will be analyzed with appropriate statistical methods and using SPSS software version 25
Participants/Inclusion and exclusion criteria
Informed and written consent of the patient to participate in the study.
Diagnosis of basal cell carcinoma confirmed by pathology
Patient unwillingness to undergo surgery or inability to undergo surgery or inability to administer intralesional medical therapy such as interferon alpha or 5-FU.
Age 18 years and older.
Size of lesions less than 2 cm
Superficial and nodular form of BCC
Multiple lesions
Intervention groups
Methylene blue 0.5mg/ml solution and formulated ointment are applied topically to the lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure is continued until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy is applied for another month.
Main outcome variables
Wound healing rate based on dermoscopic results and clinical repair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250630066310N1
Registration date:2025-07-30, 1404/05/08
Registration timing:registered_while_recruiting
Last update:2025-07-30, 1404/05/08
Update count:0
Registration date
2025-07-30, 1404/05/08
Registrant information
Name
Mahdi Razmara ferezghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 7333
Email address
razmarafm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-26, 1404/04/05
Expected recruitment end date
2026-06-26, 1405/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of formulated methylene blue basal cell carcinoma (BCC)
Public title
effect of formulated methylene blue basal cell carcinoma (BCC)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent of the patient to participate in the study.
Diagnosis of basal cell carcinoma of the skin confirmed by pathology.
Patient unwillingness to undergo surgery or inability to undergo surgery or inability to administer intralesional medical treatment such as interferon alpha or 5-FU.
Age 18 years and older.
Lesion size less than 2 cm.
Superficial and nodular form of BCC
Multiple lesions
Exclusion criteria:
Basal cell carcinoma of the skin of the morphea-like and nodular ulcerative type
Pregnancy and lactation.
History of serious drug-related complications.
Failure to complete the course of treatment.
Failure to refer for follow-up treatment.
History of cardiovascular diseases.
History of thromboembolic diseases.
Radiotherapy treatment in the relevant area
Contact with arsenic.
Weak immunity.
Presence of serious systemic disease.
Having a history of allergy or sensitivity to methylene blue.
Having a history of bleeding disorders or abnormal blood clotting.
Having a history of severe skin disorders or inflammation in the treatment area
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Dermatology clinic of Imam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2025-06-25, 1404/04/04
Ethics committee reference number
IR.MUMS.IRH.REC.1404.040
Health conditions studied
1
Description of health condition studied
Basal Cell Carcinoma
ICD-10 code
C44.310
ICD-10 code description
Basal cell carcinoma of skin of unspecified parts of face
Primary outcomes
1
Description
Primary Outcome of Complete Wound Repair After 2 Months of Treatment Initiation Based on Dermoscopic Results and Clinical Repair
Timepoint
Methylene blue 0.5mg/ml solution and formulated ointment are applied topically to the lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure is continued until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy is applied for another month.
Method of measurement
Outcomes are evaluated by measuring changes in lesion size, examining tissue repair, clinical and dermoscopic imaging.
Secondary outcomes
1
Description
The secondary outcome of the absence of ulcer recurrence after 6 months of patient follow-up
Timepoint
After the four stages of treatment, wound repair ointment will be applied to speed up the healing process.
Method of measurement
Outcomes are evaluated by measuring changes in lesion size, examining tissue repair, clinical and dermoscopic imaging. Also, if the patient agrees, tissue sampling will be used to evaluate pathology.
Intervention groups
1
Description
Intervention group: Intervention group: Methylene blue 0.5mg/ml solution and formulated ointment are applied topically on the patient's BCC lesion every two days for a month and the lesion is photographed. If the wound improves and shrinks, the same procedure will continue until complete healing, and if there is no improvement after one month, standard methylene blue photodynamic therapy will be applied for another month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Imam Reza Hospital
Full name of responsible person
Mahdi Razmara Farzaghi
Street address
Dermatology Clinic of Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3845
Email
razmarafm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah street Ghoreyshi building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Razmara
Position
professor.Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3858 3845
Email
razmarafm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Razmara
Position
Professor, Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3858 3845
Email
razmarafm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadali Kerachian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3858 3845
Email
mohammadalikerachian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of clinical trial in analysis will be published in an article after blinding patients' data
When the data will become available and for how long
Unlimited from publishing
To whom data/document is available
Researchers in medical universities
Under which criteria data/document could be used
Data are specific for this study and is not reusable
From where data/document is obtainable
Request by email to the corresponding author recorded in this registry Dr.Mahdi Razmara Email: razmarafn@mums.ac.irTel: +985138022031 Address: Dermatology department, Imam Reza hospital, Imam Reza hospital square, Avecina street, Imam Reza hospital square, Mashhad
What processes are involved for a request to access data/document
Sending a formal request with details of the needed information to the email of the person responsible for scientific inquiries. Then it will be responded to after one week by the person responsible for scientific inquiries.