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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- ECCA grading scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Melanin Index(Baseline and 20weeks.)
- Erythema Index(Baseline and 20 weeks.)
- Transepidermal Water Loss(Baseline and 20 weeks.)
Investigators
Weihui Zeng
professor
Second Affiliated Hospital of Xi'an Jiaotong University