CFH protein delivered by ice microneedles to prevent radiation-related skin fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm phase 1 trial using a 3+3 dose-escalation design to examine safety and preliminary efficacy of intradermal delivery of a CFH protein fragment via ice microneedle patches. Participants receive twice-weekly applications for a total of eight doses, starting at 0.5 mg and escalating to 1.0 mg and 2.0 mg. Primary safety outcomes include dose-limiting toxicities within 28 days, adverse events, and tolerability; preliminary efficacy is measured by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE fibrosis grading, and quality of life. The trial enrolls patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who are scheduled for postoperative adjuvant radiotherapy and meet organ function and performance status criteria.

Why it matters

Who can join: the full rules

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 × 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%.
5. Ability to understand and voluntarily sign a written informed consent form prior to any study procedures.

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. Pregnant 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.

Where it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Xingchen Peng, MD, PhD
• Email: pxx2014@163.com
• Phone: +8618980606753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.