Efficacy and Safety of a 1064-nm Nd:YAG Picosecond Laser Versus a 1927-nm Fractional Laser for Atrophic Acne Scars.

NCT07153679 | Completed DMC

• 1 other identifier: 2021013
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Atrophic acne scars are common disfiguring skin problems, especially in the Asian population prone to Post-inflammatory Hyperpigmentation (PIH), and their treatment is highly challenging. 1064 nm microlens array picosecond laser (P-MLA) based on optomechanical effect and 1927 nm segmented thulium laser (FTL) based on photothermal effect are two emerging therapeutic techniques, but there is a lack of strict clinical evidence for direct comparison in the Asian population. This study aims to directly compare the clinical efficacy, safety and tolerability of 1064 nm P-MLA and 1927 nm FTL in the treatment of atrophic acne scars in the Asian population through a randomized, half-face controlled, evaluator blind trial.

Conditions

Acne Scar; Acne Scars - Atrophic

Outcome Measures

Primary Outcomes (2)

• ECCA grading scale

  Scar shape: U-shaped sharp-edged scars (2-4 mm) = 20 points, irregular U-shaped (\>4 mm) = 25 points. Scar number: 0 scars = 0, ≤5 scars = 1, 6-20 scars = 2, \>20 scars = 3. ECCA score = Shape score × Number score. Higher score = more severe scarring.

  Baseline and 20 weeks.

• GAIS score

  GAIS score: 1 = 0%-25% improvement; 2 = 26%-50%; 3 = 51%-75%; 4 = 76%-100%. Higher score = better improvement.

  Baseline and 20 weeks.

Secondary Outcomes (3)

• Melanin Index

  Baseline and 20weeks.

• Erythema Index

  Baseline and 20 weeks.

• Transepidermal Water Loss

  Baseline and 20 weeks.

Study Arms (2)

1064-nm Nd:YAG Picosecond Laser Group

EXPERIMENTAL

1064-nm Nd:YAG Picosecond Laser Device (Picocare 450, WONTECH, Daejeon, South Korea)

Device: 1064-nm Nd:YAG Picosecond Laser

1927-nm Fractional Thulium Laser Group

EXPERIMENTAL

1927-nm Fractional Thulium Laser Device (Lavieen, WONTECH, Daejeon, South Korea)

Device: 1927-nm Fractional Thulium Laser

Interventions

1064-nm Nd:YAG Picosecond Laser DEVICE

Treatment was performed using 1064 nm Nd:YAG microlens array picosecond laser (Picocare 450, WONTECH, Daejeon, South Korea). Received three treatments, with a 4-week interval between each treatment.

1064-nm Nd:YAG Picosecond Laser Group

1927-nm Fractional Thulium Laser DEVICE

Treatment was performed using 1927-nm thulium fractional laser (Lavieen, WONTECH, Daejeon, South Korea). Received three treatments, with a 4-week interval between each treatment.

1927-nm Fractional Thulium Laser Group

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 40.
• Symmetrical atrophic acne scars on both sides of the face.

You may not qualify if:

• Uncontrolled active acne.
• Pregnant and lactating women.
• Infectious skin diseases at the treatment site.
• Have taken retinoid drugs orally within the past 6 months.
• Photosensitive individuals or those who have used photosensitive drugs within 2 weeks.
• Keloid constitution.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)