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Completed

NCT Number: NCT07153679

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

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.

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Key information

Conditions

Acne Scar Acne Scars - Atrophic

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second affiliated hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. ECCA grading scale

    Time frame: Baseline and 20 weeks.

    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.

  2. GAIS score

    Time frame: Baseline and 20 weeks.

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

Secondary outcomes

  1. Melanin Index

    Time frame: Baseline and 20weeks.

    Utilizing the DermaLab® Combo (Cortex Technology)

  2. Erythema Index

    Time frame: Baseline and 20 weeks.

    Utilizing the DermaLab® Combo (Cortex Technology)

  3. Transepidermal Water Loss

    Time frame: Baseline and 20 weeks.

    Utilizing the DermaLab® Combo (Cortex Technology)

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

Efficacy and Safety of a 1064-nm Nd:YAG Picosecond Laser Versus a 1927-nm Fractional Thulium Laser for Atrophic Acne Scars in Asian Skin: A Randomized, Split-Face, Evaluator-Blinded Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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