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
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Wound Healing and Tumor Regression in Inoperable Basal Cell Carcinoma Treated with Topical Formulated Methylene Blue
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Formulated Methylene Blue Treatment Arm
Participants in this single-arm, open-label pilot study will receive topical methylene blue-based dressing for the management of advanced or inoperable basal cell carcinoma (BCC) wounds, including morpheaform, infiltrative, or noduloulcerative subtypes.
Wound area and depth will be evaluated weekly for four weeks using standardized digital photography (30 cm distance) and sterile metallic measurement tools. Images will be analyzed with HealUp software to quantify wound area and healing progression.
The study aims to preliminarily assess the efficacy and safety of methylene blue in promoting wound healing among five patients with refractory BCC lesions who are not candidates for surgery or radiotherapy.
干预措施: Formulated Topical Methylene Blue (0.5 mg/mL) (Drug)
Formulated Methylene Blue Treatment Arm
Participants in this single-arm, open-label pilot study will receive topical methylene blue-based dressing for the management of advanced or inoperable basal cell carcinoma (BCC) wounds, including morpheaform, infiltrative, or noduloulcerative subtypes.
Wound area and depth will be evaluated weekly for four weeks using standardized digital photography (30 cm distance) and sterile metallic measurement tools. Images will be analyzed with HealUp software to quantify wound area and healing progression.
The study aims to preliminarily assess the efficacy and safety of methylene blue in promoting wound healing among five patients with refractory BCC lesions who are not candidates for surgery or radiotherapy.
干预措施: Wound Healing Gel (Drug)
结局指标
主要结局
Rate of Wound Healing and Tumor Regression in Inoperable Basal Cell Carcinoma Treated with Topical Formulated Methylene Blue
时间窗: Baseline, every week for 4 weeks during treatment, and at 8 weeks post-treatment follow-up.
The primary outcome of this study is to evaluate the efficacy of topical formulated methylene blue (0.5 mg/mL) in promoting wound healing and reducing tumor size in patients with inoperable or radiotherapy-resistant basal cell carcinoma (BCC) of morpheaform, infiltrative, and noduloulcerative subtypes. The assessment includes measurement of wound area and depth using standardized digital photography and calibrated sterile metal measurers. Images will be analyzed with the HealUp software to determine the rate of epithelialization and reduction in lesion size. The degree of tissue regeneration and clinical response will be documented before treatment and at defined follow-up intervals.
次要结局
- Changes in Inflammatory and Biochemical Markers Before and After Treatment with Topical Formulated Methylene Blue(At baseline (before treatment) and at completion of therapy (approximately 4 to 8 weeks after treatment initiation).)
研究者
Daryoush Hamidi Alamdari, PhD
Professor
Mashhad University of Medical Sciences