Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis
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
West China Hospital
60 participants
Mar 1, 2026
INTERVENTIONAL
Summary
To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria6
- 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.
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Interventions
A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07353671