Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis

Официальное название

A Single-Center, Two-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of a Topical Periplaneta Americana-Derived Regenerative Solution (Meilian Fuxin Liquid) for the Treatment of Radiation Dermatitis

Обзор

To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.

Подробное описание

The clinical trial aims to evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution in preventing and reducing radiation dermatitis in patients undergoing radiotherapy. Participants will be assigned to receive either topical Meilian Fuxin Solution or a placebo formulation, applied twice daily to the irradiated skin area from the start of radiotherapy through completion of treatment. The placebo will be administered using an identical application regimen. Radiation dermatitis will be assessed at baseline and at regular intervals during and after radiotherapy using the Radiation Therapy Oncology Group (RTOG) criteria, and safety will be evaluated by monitoring local and systemic adverse events throughout the study period.

Вмешательства

• Препарат Topical application of Periplaneta americana-derived Meilian Fuxin Solution
  A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).
• Другое Topical application of placebo
  The placebo topical formulation will be composed of inactive ingredients and will be matched in appearance, texture, and administration regimen to the active Periplaneta americana-derived Meilian Fuxin Solution, and participants will also receive standard skin care for radiation dermatitis according to institutional clinical practice guidelines.
• Лучевая терапия Radiotherapy
  One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Первичные конечные точки

• Incidence of Grade 2 or Higher Acute Radiation Dermatitis (RTOG Criteria) [Срок оценки: The evaluation period is approximately 14 weeks to 14.5 weeks.]

Вторичные конечные точки (7)

• Incidence of Grade 3 or Grade 4 Radiation Dermatitis [Срок оценки: The evaluation period is approximately 14 weeks and 14.5 weeks.]
• Time to Occurrence of Grade 3 or Grade 4 Radiation Dermatitis [Срок оценки: The evaluation period is approximately 14 weeks to 14.5 weeks.]
• The duration of any-grade Radiation Dermatitis [Срок оценки: The evaluation period is approximately 14 weeks and 14.5 weeks.]
• Change in Radiation Dermatitis Severity Score using the RISRAS Scale [Срок оценки: The evaluation period is approximately 14 weeks and 14.5 weeks.]
• Change in Patient Quality of Life using the Skindex-16 [Срок оценки: The evaluation period is approximately 14 weeks and 14.5 weeks.]
• Radiotherapy Interruption due to Radiation Dermatitis [Срок оценки: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks.]
• Adverse events [Срок оценки: The evaluation period is approximately 14 weeks and 14.5 weeks.]

Критерии участия

Критерии включения

• Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
• Diagnosis and Treatment: Patients with head and neck cancer (including nasopharyngeal carcinoma) who have been confirmed by histopathology and require radical radiotherapy or postoperative adjuvant radiotherapy.
• Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
• Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.

Критерии исключения

• Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
• Baseline Skin Condition: Baseline skin condition in the treatment area that may interfere with efficacy assessment (e.g., presence of open wounds, infection, rash, psoriasis, etc.).
• Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
• Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
• Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
• Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Sichuan University West China Hospital, Chengdu, Sichuan — Чэнду
• Sichuan University West China Hospital — Чэнду

Идентификаторы

NCT: NCT07353671 · 2025(1723)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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