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

NCT04813419 | Unknown

• 1 other identifier: 2021-0227
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrophic Acne Scar

Keywords

2940nm Er:YAG laser, 1927nm thulium laser

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Pain score

  immediately after each laser treatment

Other Outcomes (1)

• adverse effects

  through study completion, an average of 0.5 year

Study Arms (2)

right face

ACTIVE COMPARATOR

The right side of face of subjects

Device: 2940nm Er:YAG laser

left face

EXPERIMENTAL

The left side of face of subjects

Device: 1927nm thulium laser

Interventions

1927nm thulium laser DEVICE

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.

left face

2940nm Er:YAG laser DEVICE

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.

right face

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age of at least 18 years clinical diagnose of facial atrophic acne scarring

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 0571, China

RECRUITING

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Suiqing S Cai, doctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

kune K Lu, postgraduate

CONTACT

19858125820; lke225@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and outcomes assessor are blinded to laser therapy received at each side of face
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: adult patients with similar atrophic acne scar on both sides of face

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: June 11, 2020
• Primary Completion: March 20, 2021
• Study Completion: April 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)