At a glance
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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
In Brief
A Phase 3 clinical trial evaluating Topical application of Periplaneta americana-derived Meilian Fuxin Solution, Topical application of placebo, and 1 other intervention for Radiation-induced Dermatitis. Currently recruiting, targeting 60 participants across 2 sites.
Detailed 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.
Study Details
Timeline
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.