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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05555602
Eligibility Criteria:
Inclusion Criteria:
1. Age 14-60 years;
2. The patient agreed to participate in the experiment and signed the informed consent by himself/herself or his/her legal representative;
3. The clinical diagnosis was burn scar or post-operative linear scar, and the total area was more than 5 cm2.
4. No other treatment such as laser or chemical exfoliation was performed on the lesion within the recent half year.
5. Skin lesions were free of bleeding, ulceration, infection and other conditions affecting the visual field of laser treatment.
Exclusion Criteria:
1. Patients with an active or established sun tan;
2. Patients with history of allergic reaction to to topical anesthesia;
3. Patients with history of keloid scarring, abnormal wound healing and/or prone to bruising;
4. Skin malignant tumors or precancerous lesions;
5. Patients with diabetes, heart disease, epilepsy, connective tissue disease, etc.;
6. Pregnant or breastfeeding patients;
7. Patients with recent skin infections (such as viral and bacterial infections);
8. Patients who are using other methods to treat similar diseases;
9. Patients who had taken isotretinoin within the past year;
10. History of cryoglobulinaemia;
11. History of cold agglutinin disease and cold haemolysis;
12. History of cold urticaria;
13. Parts of the body with impaired circulation;
14. Raynaud's disease;
15. Parts of the body with impaired sensitivity;
16. Trophic disorders;
17. Hypersensitivity to cold;
18. Patients with mental illness;
19. Other ineligible patients.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
60 Years
Study:
NCT05555602
Study Brief:
Protocol Section:
NCT05555602