NCT07353671

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Radiation-induced Dermatitis

Interventions

Type	Name	Description
DRUG	Topical application of Periplaneta americana-derived Meilian Fuxin Solution	A topical formulation derived from Periplaneta americana (Meilian Fuxin Solution).
OTHER	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.
RADIATION	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2026-01-20
• Last updated: 2026-03-25

Locations

2 sites across 1 country: China