Basal Cell Carcinoma. Other and unspecified malignant neoplasm of skin, unspecified
Conditions
Interventions
Intervention: A 0.5 mg/ml formulated methylene blue solution or ointment will be applied topically to the BCC lesion every two days for one month, with clinical photographs taken at each dressing chan
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histopathologically confirmed diagnosis of morpheaform, infiltrative, or noduloulcerative basal cell carcinoma (BCC) 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
Exclusion criteria: Superficial or nodular subtype of basal cell carcinoma 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the evaluation of complete lesion (wound) healing within two months from the initiation of treatment with formulated methylene blue, based on clinical and dermoscopic findings. Timepoint: Formulated methylene blue at a concentration of 0.5 mg/mL, in either solution or ointment form, will be applied topically to the lesion every other day for one month, with photographic documentation at each session. If a reduction in lesion size or visible improvement is observed, the same regimen will be continued until complete healing is achieved. In cases where no improvement is detected after one month, standard photodynamic therapy with methylene blue will be administered for an additional month. Method of measurement: Lesion dimensions before and after treatment will be measured using clinical photography and dermoscopic imaging. Depth of involvement and extent of tissue repair will be assessed. Captured images will be analyzed using image-processing software to calculate lesion surface area and quantify the rate of healing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of lesion recurrence within six months following complete healing, along with evaluation of treatment tolerability and potential adverse effects. Timepoint: Follow-up visits will be conducted monthly for six months after full clinical resolution of the lesion. Method of measurement: Recurrence will be assessed through clinical and dermoscopic examination of the treated area. Patient-reported symptoms such as pain, pruritus, or burning sensation will be documented using a standardized questionnaire. Local or systemic adverse reactions (e.g., erythema, irritation, infection) will be recorded and graded according to standardized dermatologic toxicity criteria. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDaryoush Hamidi Alamdari
Mashhad University of Medical Sciences
Outcome results
None listed