Condition: Radiation-Induced Skin Fibrosis · Head and Neck Squamous Cell Carcinoma · Sponsor: West China Hospital
This phase I, open-label, single-arm, non-randomized clinical trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin fibrosis in patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) receiving postoperative adjuvant radiotherapy. The main questions are: 1. The safety profile, including dose-limiting toxicities (DLTs) within 28 days after the first dose, adverse events, and tolerability. 2.Preliminary efficacy, assessed by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE grade ≤2 fibrosis rate, and quality of life. Participants receive CFH ice microneedle patches twice weekly for a total of 8 doses (starting at 0.5 mg, escalating to 1.0 mg and 2.0 mg), applied to the skin area to be irradiated.
This description comes directly from the study's public registry record.
Xingchen Peng, MD, PhD · +8618980606753 · pxx2014@163.com
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| West China Hospital, Sichuan University | Chengdu, Sichuan, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07567235