Acne ScarNCT07153679
Efficacy and Safety of a 1064-nm Nd:YAG Picosecond Laser Versus a 1927-nm Fractional Laser for Atrophic Acne Scars.
A study testing 1064-nm Nd:YAG Picosecond Laser and 1927-nm Fractional Thulium Laser in people with Acne Scar and Acne Scars - Atrophic, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Scar, Acne Scars - Atrophic
- What is being tested?
- 1064-nm Nd:YAG Picosecond Laser and 1927-nm Fractional Thulium Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 40.
- Symmetrical atrophic acne scars on both sides of the face.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710000
About this study
Official 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.
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
- Being tested
- 1064-nm Nd:YAG Picosecond Laser, 1927-nm Fractional Thulium Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064-nm Nd:YAG Picosecond LaserDevice
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 LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1064-nm Nd:YAG Picosecond Laser Group | Experimental | 1064-nm Nd:YAG Picosecond Laser Device (Picocare 450, WONTECH, Daejeon, South Korea) Receives: 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) Receives: Device: 1927-nm Fractional Thulium Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 20 weeks.
Secondary outcomes (3)
Melanin Index
Utilizing the DermaLab® Combo (Cortex Technology)
Measured: Baseline and 20weeks.
Erythema Index
Utilizing the DermaLab® Combo (Cortex Technology)
Measured: Baseline and 20 weeks.
Transepidermal Water Loss
Utilizing the DermaLab® Combo (Cortex Technology)
Measured: Baseline and 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Jan 2021
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153679
- Sponsor's protocol ID
- 2021013
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07153679
- Acronym / sponsor ID
- 2021013
- Conditions
- Acne Scar, Acne Scars - Atrophic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1064-nm Nd:YAG Picosecond Laser Group | Experimental | Device: 1064-nm Nd:YAG Picosecond Laser1064-nm Nd:YAG Picosecond Laser Device (Picocare 450, WONTECH, Daejeon, South Korea) |
| 1927-nm Fractional Thulium Laser Group | Experimental | Device: 1927-nm Fractional Thulium Laser1927-nm Fractional Thulium Laser Device (Lavieen, WONTECH, Daejeon, South Korea) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 40.
- Symmetrical atrophic acne scars on both sides of the face.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1064-nm Nd:YAG Picosecond LaserTreatment 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. | Device | 1064-nm Nd:YAG Picosecond Laser Group |
| 1927-nm Fractional Thulium LaserTreatment was performed using 1927-nm thulium fractional laser (Lavieen, WONTECH, Daejeon, South Korea). Received three treatments, with a 4-week interval between each treatment. | Device | 1927-nm Fractional Thulium Laser Group |
Primary outcome
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.
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.
3 secondary outcomes
Melanin Index
Time frame: Baseline and 20weeks.
Erythema Index
Time frame: Baseline and 20 weeks.
Transepidermal Water Loss
Time frame: Baseline and 20 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064-nm Nd:YAG Picosecond Laser and 1927-nm Fractional Thulium Laser in people with Acne Scar and Acne Scars - Atrophic, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECCA grading scale (time frame: Baseline and 20 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.