Clinical Study of CFH Protein Via Ice Microneedles for Radiation-Induced Skin Fibrosis

Summary

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.

Timeline

Start

2026-06-15

Primary completion

2027-03-01

Completion

2027-03-01

Publications

• Background Jozsi M, Schneider AE, Karpati E, Sandor N. Complement factor H family proteins in their non-canonical role as modulators of cellular functions. Semin Cell Dev Biol. 2019 Jan;85:122-131. doi: 10.1016/j.semcdb.2017.12.018. Epub 2018 Jan 5.
• Background Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.
• Background Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9. doi: 10.1016/j.radonc.2004.09.013.
• Background Fijardo M, Kwan JYY, Bissey PA, Citrin DE, Yip KW, Liu FF. The clinical manifestations and molecular pathogenesis of radiation fibrosis. EBioMedicine. 2024 May;103:105089. doi: 10.1016/j.ebiom.2024.105089. Epub 2024 Apr 5.
• Background Straub JM, New J, Hamilton CD, Lominska C, Shnayder Y, Thomas SM. Radiation-induced fibrosis: mechanisms and implications for therapy. J Cancer Res Clin Oncol. 2015 Nov;141(11):1985-94. doi: 10.1007/s00432-015-1974-6. Epub 2015 Apr 25.
• Background Mayor S. WHO priority list of medical devices for cancer management. Lancet Oncol. 2017 Jul;18(7):856. doi: 10.1016/S1470-2045(17)30407-2. Epub 2017 May 25. No abstract available.

Drugs

Indications