Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04813419
Status:
UNKNOWN
Last Update Posted:
2021-03-24
First Post:
2021-03-17
Brief Title:
2940nm ErYAG Laser and 1927nm Thulium Laser in Improving Atrophic Acne Scars
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Efficacy and Safety Comparison Between Fractional 2940nm ErYAG Laser and Fractional 1927nm Thulium Laser in the Treatment of Facial Atrophic Acne Scars
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fractional non-ablative laser FNAL has been widely used in improving acne scarring However there was only one study reported efficacy and safety of the fractional non-ablative 1927nm thulium laser FTL and no studies have reported a comparison between FTL and fractional ablative 2940nm ErYAG laserFEL which had been proved effective and safety in many studies Thus we designed a prospective simultaneous spilt-face trial to evaluate the efficacy and safety of FTL in the treatment of acne scarring and make a comparison between FTL and FEL hoping to provide a new available modality for patients who are intolerable or reluctant to ablative lasers
Detailed Description:
Acne vulgaris is a chronic and recalcitrant inflammation of pilosebaceous unit that has a high incidence rate in adolescence and even adults Acne scarring is not an uncommon cosmetic complication which will cause physical and phycological pressure and impair the life quality of patients It can be divided into two types according to morphology atrophic and hypertrophic acne scarring Atrophic acne scarring can be subclassified into boxcar icepick and rolling scarring due to morphological features Although a great variety of modalities to treat atrophic acne scarring such as chemical peeling lasers and light micro-needling and radiofrequency have emerged fractional laser FL have come out on top Unlike resurfacing lasers FL creates three-dimensional evenly distributed microscopic thermal zonesMTZson the treating area which only covering about 3-40 of the skin and leaving the surrounding tissue undamaged and serving as cell reservoir Then the MTZs can be rapidly replaced by keratinocytes in cell reservoir within the first 24 hours and by new collagen within 3-6 months FL can be categoried into fractional ablative laserFAL and fractional non-ablative laserFNAL
With a wavelength of 2940nm FEL could be highly absorbed by water-containing tissues of skin and cause superficial epidermis ablation and collagen induction4 But thermal damage is limited to about 20-50um FTL has a moderate affinity for water content tissue Thus rather than causing epidermis turnover it keeps the epidermis intact But it can penetrate deep into 200-300um and stimulate collagen regeneration Prior studies have shown that both FAL and FNAL were effective in treating acne scarring and the former were more effective while the latter had less side effects However in our clinic we have observed outstanding effect and high satisfaction rate of FTL in improving atrophic acne scarring Since there was only one clinical trial reported the efficacy and safety of FTL in Asian and no study have made a comparison between FTL and FEL we designed this prospective simultaneous spilt-face trial hoping to provide a new available modality for patients who are intolerable or reluctant to ablative lasers
With a wavelength of 2940nm FEL could be highly absorbed by water-containing tissues of skin and cause superficial epidermis ablation and collagen induction4 But thermal damage is limited to about 20-50um FTL has a moderate affinity for water content tissue Thus rather than causing epidermis turnover it keeps the epidermis intact But it can penetrate deep into 200-300um and stimulate collagen regeneration Prior studies have shown that both FAL and FNAL were effective in treating acne scarring and the former were more effective while the latter had less side effects However in our clinic we have observed outstanding effect and high satisfaction rate of FTL in improving atrophic acne scarring Since there was only one clinical trial reported the efficacy and safety of FTL in Asian and no study have made a comparison between FTL and FEL we designed this prospective simultaneous spilt-face trial hoping to provide a new available modality for patients who are intolerable or reluctant to ablative lasers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None