Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04106258
Eligibility Criteria:
Inclusion Criteria:
* Children with clinical diagnosis of PWS；
* ≥2 years old and \<7 years old；
* The guardians agreed to voluntarily participate in this study and signed the informed consent agreement
Exclusion Criteria:
* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;
* Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;
* with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;
* Cicatricial constitution;
* Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;
* Electrocardiographic abnormalities or organic heart diseases;
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN);
* Coagulation disorders;
* Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;
* Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；
* Previous therapy of PWS within the last 4 weeks;
* Participation in any clinical studies within the last 4 weeks;
* Be judged not suitable to participate the study by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT04106258
Study Brief:
Protocol Section:
NCT04106258