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effect of formulated methylene blue basal cell carcinoma (BCC)

Evaluation of the effect of formulated methylene blue basal cell carcinoma (BCC)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250630066310N1
Enrollment
20
Registered
2025-07-30
Start date
2025-06-26
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma. Basal cell carcinoma of skin of unspecified parts of face

Interventions

Intervention group: Intervention group: Methylene blue 0.5mg/ml solution and formulated ointment are applied topically on the patients BCC lesion every two days for a month and the lesion is photograp

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Razmara

Mashhad University of Medical Sciences

razmarafm@mums.ac.ir+98 51 3858 3845

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026