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A Prospective, Split-Face, Randomized Study Comparing a 532-nm Picosecond Laser With and Without Microlens Array in the Treatment of Solar Lentigines in Thai patients

A Prospective, Split-Face, Randomized Study Comparing a 532-nm Picosecond Laser With and Without Microlens Array in the Treatment of Solar Lentigines in Thai patients

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230417009
Enrollment
27
Registered
2023-04-17
Start date
2022-12-13
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

Solar lentigines Picosecond Fractional Solar lentigines

Interventions

Volunteers receive 532 nm picosecond laser, flat optics on solar lentigines of one side of the face for 1 time.,Volunteers receive 532 nm picosecond laser, using MLA on solar lentigines of one side of
Active Comparator Device,Experimental Device
532 nm picosecond laser, flat optics,532 nm picosecond laser, MLA

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Asian with Fitzpatrick Skin type III-V 2. Was diagnosed by a physician as Solar lentigines by a research physician. 3. Solar lentigines are on both sides of the face, and the lesion size is greater than 6 mm.

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Patients with dermatitis, wounds, or skin infections on the face 3. Patients with a history of allergy to anesthetics and cannot use cold air during treatment. 4. Patients with other diseases related to pigmentation abnormalities, such as melasma, hori nevus, nevus of ota, freckles, etc., in the same area with solar lentigines 5. Patients with a history of solar lentigines treatment with topical medications, chemical peels, or facial lasers within three months prior to participation in the study. 6. Patients with a history of herpes on the face or suffering from herpes on the face 7. Patients with mental disorders whom a psychiatrist has diagnosed. 8. Patients considered by the researcher to be unsafe if participating in the program 9. Patients who are not allowed to take pictures for treatment evaluation

Design outcomes

Primary

MeasureTime frame
Incidence of PIH following treatment 2 weeks, 1 month, 3 months , 6 months after treatment Clinical evaluation

Secondary

MeasureTime frame
Average melanin concentration Before, 2 weeks, 1 month, 3 months, 6 months after treatment Antera 3D analysis

Countries

Thailand

Contacts

Public ContactThrit Hutachoke

Faculty of Medicine Siriraj Hospital, Mahidol University

maxover2@gmail.com0818032865

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026