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

Exclusion Criteria8

• 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;
• 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.).
• 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.
• 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.
• Participation in another clinical trial of a drug or device within 3 months prior to screening.
• History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism or drug addiction).
• Pregnant or breastfeeding women, or women/partners planning pregnancy during the period from screening through 12 months after the last dose.
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.