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

Prior treatment

• Known allergy to the investigational drug (including any excipients) or history of severe allergic reactions to any drug, food, or vaccine, such as anaphylactic shock, laryngeal edema, anaphylactic dyspnea, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction.
• Participation in another clinical trial of a drug or device within 3 months prior to screening.

Other illness

• Presence of connective tissue disease or other systemic dermatologic conditions (e.g., systemic lupus erythematosus, dermatomyositis, polymyositis, systemic sclerosis, scleroderma, toxic epidermal necrolysis, Stevens-Johnson syndrome, etc.).
• Any uncontrolled clinical disease (e.g., respiratory, circulatory, digestive, nervous, hematologic, genitourinary, or endocrine system disease) or psychiatric disorder (e.g., depression, schizophrenia) that, in the investigator's judgment, would interfere with providing informed consent, interpretation of study results, pose additional risk to the patient, or otherwise compromise study objectives.
• History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism or drug addiction).
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.

Lab values

• Presence of ulceration or open wound in the treatment area, or any contraindication to cutaneous administration including: Inflammation, trauma, or skin breakdown at the administration site; Severe bleeding or coagulation tendency (e.g., markedly low platelet or clotting factors); Any abnormality or permanent body art (e.g., tattoo) at the administration site that would interfere with observation of local reactions;

Other

• Pregnant or breastfeeding women, or women/partners planning pregnancy during the period from screening through 12 months after the last dose.

• Male or female patients aged 18 to 75 years (inclusive) at screening.
• Histologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) scheduled to receive postoperative adjuvant radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Adequate major organ function within 7 days before treatment, meeting the following criteria:
  • Hemoglobin ≥ 80 g/L; neutrophil count \> 1.5 × 10⁹/L; platelet count ≥ 80 × 10⁹/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT or AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN (unless on warfarin anticoagulation); Left ventricular ejection fraction (LVEF) ≥ 50%.
• Ability to understand and voluntarily sign a written informed consent form prior to any study procedures.