Набор по приглашению NCT07311070

Treatment of Basal Cell Carcinoma (BCC) of the Skin, of the Morpheiform, Infiltrative, and Noduloulcerative Types in Inoperable Patients and Not Suitable for Radiotherapy Using Formulated Methylene Blue

Фаза III С лечением Advanced Basal Cell Carcinoma (BCC) Inoperable Disease Morpheaform Basal Cell Carcinoma Noduloulcerative Basal Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Formulated Topical Methylene Blue (0.5 mg/mL), Wound Healing Gel.
Кому может быть актуально: Состояния в реестре: Advanced Basal Cell Carcinoma (BCC), Inoperable Disease, Morpheaform Basal Cell Carcinoma, Noduloulcerative Basal Cell Carcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Иран
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to evaluate whether formulated methylene blue can safely and effectively treat advanced or inoperable basal cell carcinoma (BCC), 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 BCC? 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.

Вмешательства

Препарат Formulated Topical Methylene Blue (0.5 mg/mL)
Participants will receive a topical formulation of methylene blue at a concentration of 0.5 mg/mL, applied directly to the basal cell carcinoma (BCC) lesions of the morpheaform, infiltrative, or noduloulcerative type. The formulation will be administered every two days for a period of one month. The topical preparation is designed with a standard cream base containing carrier oils and lipids to enhance penetration into deeper skin layers and facilitate the delivery of the active compound. Additi
Препарат Wound Healing Gel
Following completion of the methylene blue treatment, a wound healing gel will be applied to the treated lesions. This gel, which contains platelet-rich fibrin and other supportive compounds, has demonstrated efficacy in removing necrotic tissue and promoting tissue regeneration. The gel will be used until complete wound closure is achieved.

Первичные конечные точки

Rate of Wound Healing and Tumor Regression in Inoperable Basal Cell Carcinoma Treated with Topical Formulated Methylene Blue [Срок оценки: Baseline, every week for 4 weeks during treatment, and at 8 weeks post-treatment follow-up.]

Вторичные конечные точки (1)

Changes in Inflammatory and Biochemical Markers Before and After Treatment with Topical Formulated Methylene Blue [Срок оценки: At baseline (before treatment) and at completion of therapy (approximately 4 to 8 weeks after treatment initiation).]

Критерии участия

Критерии включения

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