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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT04648995
Eligibility Criteria:
Inclusion Criteria:
* Subjects have to be aged from 20 to 60 year-old
* Subjects currently have an area of involvement approximately 2cm × 2cm on each side of the face over the temples or cheek bone area
* Classified as mild to moderate acne scar according to global severity of facial acne scar (GSAAS) score
* After evaluation by clinician, those subjects to be treated with "Lumenis"CO2 Laser System (UltraPulse) can benefit from this laser treatment
* Subjects need to be fully functional and aware of the pros and cons of the study. Subject is capable to make self judgement and sign the inform consent under his/her own will
* Others: Have fully understand about this study and is willing to cooperate with the instruction of the study
Exclusion Criteria:
* Those who were known to have keloid formation
* Those who have porphyria or known photosensitivity
* Those who previously underwent laser therapy treatment or skin biopsy and have showed poor result or adverse effect
* Those who were classified as "severe" according to GSAAS system
* Those who have bleeding tendency
* Those who present with clinical data suggesting abnormal platelet function or coagulation disorder (such as prolonged aPTT or PT)
* Those that are currently taking anticoagulants or anti-platelet drugs
* Those who are on aspirin or other NSAIDs
* Those who have history of granulomatous or connective tissue disease
* Female subjects with a positive pregnancy test
* Women who refuse to stay on effective contraception or refuse pregnancy tests during the study
* After evaluation by the clinician, those that have been enrolled in clinical studies over the past 6 months that may alter the current study result
* After evaluation by the clinician, those currently or had previous treatment of atrophic acne scars with fillers, lasers, deep chemical peels, or any other medical or surgical treatment which in the investigators' opinion could alter the results of the current clinical study
* Those that are currently taking photo-sensitive drugs, oral isotretinoin, iron supplement or other herbal medication
* Those that have received laser treatment over the lesion area over the past 3 months
* Those that are currently pregnant or breastfeeding
* After evaluation by the clinician, and concluded underline epilepsy, area to be treated is under infection or ulceration, poor wound healing)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT04648995
Study Brief:
Protocol Section:
NCT04648995