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

Primary Purpose

Atrophic Acne Scar

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
1927nm thulium laser
2940nm Er:YAG laser
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Acne Scar focused on measuring 2940nm Er:YAG laser, 1927nm thulium laser

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

right face

left face

Arm Description

The right side of face of subjects

The left side of face of subjects

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 17, 2021
Last Updated
March 21, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04813419
Brief Title
2940nm Er:YAG Laser and 1927nm Thulium Laser in Improving Atrophic Acne Scars
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scar
Keywords
2940nm Er:YAG laser, 1927nm thulium laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
adult patients with similar atrophic acne scar on both sides of face
Masking
ParticipantOutcomes Assessor
Masking Description
patients and outcomes assessor are blinded to laser therapy received at each side of face
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
right face
Arm Type
Active Comparator
Arm Description
The right side of face of subjects
Arm Title
left face
Arm Type
Experimental
Arm Description
The left side of face of subjects
Intervention Type
Device
Intervention Name(s)
1927nm thulium laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
2940nm Er:YAG laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Goodman&Baron quantitative global scarring grading system (GBS)
Description
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).
Time Frame
GBS change from baseline(T0) at 1 hour before the third session(T1) and 3 months after the final treatment(T2)
Title
self-rated acne scar improvement
Description
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.
Time Frame
3 months after the final treatment(T2)
Title
self-rated satisfaction score
Description
It is evaluated by subjects themselves. Satisfaction score ranged from 0 to 10: 0 meant not satisfied and 10 meant very satisfied.
Time Frame
3 months after the final treatment(T2)
Secondary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
immediately after each laser treatment
Other Pre-specified Outcome Measures:
Title
adverse effects
Description
Adverse reactions such as pain, erythema and edema, hyperpigmentation and hypopigmentation were recorded.
Time Frame
through study completion, an average of 0.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kune K Lu, postgraduate
Phone
19858125820
Ext
86
Email
lke225@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suiqing S Cai, doctor
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
0571
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suiqing S Cai, doctor
Phone
13957107910
Email
2191008@zju.edu.cn

12. IPD Sharing Statement

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

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

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