Radiation-induced skin fibrosis
Conditions
Interventions
Low-dose group:CFH Protein-loaded Ice Microneedles (0.5 mg)
Medium-dose group:CFH Protein-loaded Ice Microneedles (1.0 mg)
High-dose group:CFH Protein-loaded Ice Microneedles (2.0 mg)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 75 years (inclusive) at screening; 2. Histologically confirmed head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) scheduled to receive postoperative adjuvant radiotherapy; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4. Adequate major organ function within 7 days before treatment, meeting the following criteria: Hemoglobin >= 80 g/L; neutrophil count > 1.5 × 10?/L; platelet count >= 80 × 10?/L; Total bilirubin = 60 mL/min (Cockcroft-Gault formula); Prothrombin time (PT) and international normalized ratio (INR) = 50%; 5. Ability to understand and voluntarily sign a written informed consent form prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. 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; 2. 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.); 3. 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; 4. 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; 5. Participation in another clinical trial of a drug or device within 3 months prior to screening; 6. History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism or drug addiction); 7. regnant or breastfeeding women, or women/partners planning pregnancy during the period from screening through 12 months after the last dose; 8. Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events, AE;Number of occurrences of dose-limiting toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Thickness of skin in the irradiated area;Surface area and volume of the skin fibrosis region;Number of subjects with radiation fibrosis grade = 2;Quality of life score (QoL score); | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital, Sichuan University
Outcome results
None listed