Topical Meilian Fuxin liquid to prevent radiation dermatitis in head and neck cancer

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

This trial will test whether applying Meilian Fuxin liquid to the skin twice daily can prevent radiation dermatitis in people receiving radiotherapy for head and neck cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT07353671 on ClinicalTrials.gov

What this trial studies

This interventional phase 2/3 trial compares topical Periplaneta americana–derived Meilian Fuxin Solution with an identical placebo applied twice daily to the irradiated skin from the start through the end of radiotherapy. Participants are assigned to receive either the active solution or placebo and skin reactions are measured at baseline and at regular intervals using RTOG criteria. Safety is monitored by recording local and systemic adverse events throughout treatment and follow-up. The trial is conducted at Sichuan University West China Hospital and targets patients receiving radical or adjuvant radiotherapy for head and neck cancers.

Who should consider this trial

Good fit: Adults aged 18–80 with histologically confirmed head and neck cancer who require radical or postoperative radiotherapy and have an ECOG performance status of 0–2 are appropriate candidates.

Not a fit: Patients with prior radiotherapy to the target area, baseline skin problems in the treatment field, connective tissue or systemic dermatoses, or known allergy to the product are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the treatment could reduce the frequency or severity of radiation dermatitis, improving patient comfort and helping patients complete radiotherapy without interruption.

How similar studies have performed: Some small clinical reports and preclinical studies suggest Periplaneta-derived preparations may aid wound healing, but high-quality randomized evidence for preventing radiation dermatitis is limited, so this application is relatively novel.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• Sichuan University West China Hospital, Chengdu, Sichuan — Chengdu, Sichuan, China (Recruiting)
• Sichuan University West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xingchen Peng — West China Hospital
• Study coordinator: Xingchen Peng

Conditions Radiation-induced Dermatitis; Head & neck cancer; Meilian Fuxin Solution