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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrophic Acne Scar
• Intervention / Treatment: Device: 2940nm Er:YAG laser; Device: 1927nm thulium laser

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kune K Lu, postgraduate; Phone Number: 86 19858125820; Email: lke225@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • Recruiting
      • Zhejiang University
      • Contact: Suiqing S Cai, doctor; Phone Number: 13957107910; Email: 2191008@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: right face; The right side of face of subjects	Device: 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.
Experimental: left face; The left side of face of subjects	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse effects	Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.	through study completion, an average of 0.5 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Suiqing S Cai, doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Anticipated): March 20, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: 2940nm Er:YAG laser, 1927nm thulium laser
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 2021-0227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Since the individual participant data(IPD) is personal information, our participants are unwilling to share. But we welcome any questions through emails.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No