Topical Periplaneta Americana-Derived Meilian Fuxin Liquid for Radiation Dermatitis

Sichuan University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Radiation-induced Dermatitis

Treatments: Other: Topical application of placebo; Radiation: Radiotherapy; Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07353671

2025(1723)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
2. 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.
3. Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
4. Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

1. Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
2. 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.).
3. Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
4. Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
5. Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
6. Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Meilian Fuxin Solution

Experimental group

Description:

Topical application of Periplaneta americana-derived Meilian Fuxin Solution

Treatment:

Drug: Topical application of Periplaneta americana-derived Meilian Fuxin Solution

Radiation: Radiotherapy

Control group

Placebo Comparator group

Description:

Topical application of placebo

Treatment:

Radiation: Radiotherapy

Other: Topical application of placebo