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:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT03125057
Eligibility Criteria:
Inclusion Criteria:
* Children with clinical diagnosis of PWS；
* Age range: 7 to 14 years-old；
* Voluntarily participated and Written informed consent signed
Exclusion Criteria:
* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
* Scar diathesis;
* Immunocompromised conditions;
* Electrocardiographic abnormalities or organic heart diseases;
* Coagulation disorders;
* 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);
* Psychiatric diseases; Severe endocrinopathies;
* 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:
7 Years
Maximum Age:
14 Years
Study:
NCT03125057
Study Brief:
Protocol Section:
NCT03125057