2940nm Er:YAG Laser and 1927nm Thulium Laser in Improving Atrophic Acne Scars

Atrophic Acne Scar Clinical Trial

Official title:

Efficacy and Safety Comparison Between Fractional 2940nm Er:YAG Laser and Fractional 1927nm Thulium Laser in the Treatment of Facial Atrophic Acne Scars

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813419
• Other study ID #: 2021-0227
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: April 2021

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: kune K Lu, postgraduate
• Phone: 19858125820
• Email: lke225[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Er:YAG laser(FEL), 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.

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 zones(MTZs)"on 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 laser(FAL) and fractional non-ablative laser(FNAL). With a wavelength of 2940nm, FEL could be highly absorbed by water-containing tissues of skin and cause superficial epidermis ablation and collagen induction[4]. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

age of at least 18 years clinical diagnose of facial atrophic acne scarring Exclusion Criteria: there was infection in the treatment site Acne vulgaris were not controlled had a propensity for keloid forming received oral isotretinoin or laser treatment in the past 3 months received chemical peeling 1 month before the study pregnancy or breast-feeding.

Related Conditions & MeSH terms

• Atrophic Acne Scar
• Atrophy

Intervention

Device:
• 1927nm thulium laser
The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. The left face of subjects were treated with fractional 1927nm thulium laser(Lavieen, korea). Parameters were set as stamp mode, a spot size of 5*5mm, a pulse time of 1000us, an energy intensity of 3645mJ/cm2 and a repetition of 1-3 times. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.
• 2940nm Er:YAG laser
The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.

Locations

Country	Name	City	State
China	Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse effects	Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.	through study completion, an average of 0.5 year
Primary	Goodman&Baron quantitative global scarring grading system (GBS)	It is evaluated by a blinded dermatologist. It is a international criteria evaluating acne scar according to scar number and type. Tpye :(A) Milder scarring(1 point each): macular erythematous or pigmented and mildly atrophic dish-like;(B)Moderate scarring(2 points each) :moderately atrophic dish-like, punched out with shallow bases, small scarring(<5mm), shallow but broad atrophic areas;(C)Severe scarring(3 points each): punched out with deep but normal bases, small scarring(<5mm), punched out with deep abnormal bases, small scarring(<5mm), linear or troughed dermal scarring, deep, broad atrophic areas. Scar numbers:1-10(1 point each), 11-20(2 points each),>20(3 points each).	GBS change from baseline(T0) at 1 hour before the third session(T1) and 3 months after the final treatment(T2)
Primary	self-rated acne scar improvement	It is evaluated by subjects themselves. Self-rated acne scar improvement ranged from 0 to 4, 0 meant no improvement, 1 represented 1-25% improvement, 2 represented 26-50% improvement, 3 represented 51-75% improvement and 4 represented 76-100% improvement.	3 months after the final treatment(T2)
Primary	self-rated satisfaction score	It is evaluated by subjects themselves. Satisfaction score ranged from 0 to 10: 0 meant not satisfied and 10 meant very satisfied.	3 months after the final treatment(T2)
Secondary	Pain score	It is evaluated by subjects themselves with Visual analogue scale(VAS) , on a scale from 0 to 10, 0 meant no pain while 10 meant extremely painful.	immediately after each laser treatment