The efficacy of fractional and collimated Picosecond Nd:YAG 1,064-nm laser for the treatment of Melasma: a split-face, single-blinded, randomized study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250716011

Enrollment

Registered

2025-07-16

Start date

2025-07-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed-type facial melasma Melanosis, Fractional picosecond Nd:YAG 1,064-nm laser, Collimated picosecond Nd:YAG 1,064-nm laser

Interventions

The half of facial area is applied with numbness cream and treated with combined fractional and collimated picosecond 1,064 nm laser. ,The other half of the face is treated with collimated picosecond

Experimental Procedure/Surgery,Active Comparator Procedure/Surgery

Combined fractional and collimated picosecond laser,Conventional collimated picosecond laser

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged 18 years or older. 2. In good general health with no serious underlying diseases. 3. Presence of mixed-type melasma on both sides of the face with symmetrical distribution. 4. Able to attend scheduled visits and comply with study procedures. 5. Willing to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Received laser treatment, intense pulsed light (IPL), or chemical peeling for melasma within the past 2 months. 2. Used topical treatment for melasma within the past month. 3. Immunocompromised individuals. 4. Active skin infections or inflammation at the treatment site. 5. Open wounds or ulcers at the treatment area. 6. History of skin cancer. 7. Presence of infectious skin conditions or recurrent herpes infection. 8. Uncontrolled inflammatory acne (acne vulgaris). 9. History of keloid scarring. 10. Pregnant or breastfeeding women. 11. History of photosensitivity. 12. Known allergy to topical anesthetics.

Design outcomes

Primary

Measure	Time frame
modified melasma area and severity index at 0, 4, 8, 12, 16, and 20 weeks The picture of face was sent to a blinded dermatologist to evaluate the modified melasma area and severity index.	—

Secondary

Measure	Time frame
Pigment score of Antera3D imaging system at 0, 4, 8, 12, 16, and 20 weeks The digital photograph is access automatic with Antera3D imaging system utilized the pigment evaluation.,Lightness index at 0, 4, 8, 12, 16, and 20 weeks By using a Colorimeter measures the melasma area at the malar prominent.,Overall aesthetic improvement scale at 20 week The before and after treatment at 20week digital photographs will send to a blinded-dermatologist to evaluate the overall aesthetic improvement scale utilized the visual analog scale.,Patient satisfaction score at 20 week The before and after treatment at 20week digital photographs will send to a patient to evaluate the satisfaction score utilized the visual analog scale.,Pain score at 0, 4, and 8 weeks After the laser treatment the patient will receive the pain score evaluation form using visual analog scale,The adverse events at 0, 4, 8, 12, 16, and 20 weeks The adverse events will be evaluated by both dermatologist and patient in every appointments	—

Measure

Time frame

Pigment score of Antera3D imaging system at 0, 4, 8, 12, 16, and 20 weeks The digital photograph is access automatic with Antera3D imaging system utilized the pigment evaluation.,Lightness index at 0, 4, 8, 12, 16, and 20 weeks By using a Colorimeter measures the melasma area at the malar prominent.,Overall aesthetic improvement scale at 20 week The before and after treatment at 20week digital photographs will send to a blinded-dermatologist to evaluate the overall aesthetic improvement scale utilized the visual analog scale.,Patient satisfaction score at 20 week The before and after treatment at 20week digital photographs will send to a patient to evaluate the satisfaction score utilized the visual analog scale.,Pain score at 0, 4, and 8 weeks After the laser treatment the patient will receive the pain score evaluation form using visual analog scale,The adverse events at 0, 4, 8, 12, 16, and 20 weeks The adverse events will be evaluated by both dermatologist and patient in every appointments

—

Countries

Thailand

Contacts

Public ContactVasanop Vachiramon

Faculty of Medicine Ramathibodi hospital, Mahidol university

vasanop@gmail.com022011211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026