Hori nevus, Dermal Pigmented Lesions 1064 Picosecond Laser, Hori nevus, Dermal Pigmented Lesions
Conditions
Interventions
One side of the face will be randomly assigned to treatment with a fractional 1064 nm picosecond laser using an 8 mm fractional handpiece, delivered at a fluence of 1.1 J/cm2 with 10 overlapping passe
Experimental Device,Active Comparator Device
Fractional Picosecond 1064 nm laser,Conventional Picosecond 1064 nm laser
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 50 years, either male or female. 2. Thai individuals of Asian ethnicity. 3. Fitzpatrick skin types III to V. 4. Diagnosed with Hori nevus by a dermatologist. 5. Willing to undergo treatment with a 1064 nm picosecond laser using both full beam and fractional modes on each side of the face according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant or breastfeeding; menstrual history will be obtained prior to enrollment, and a pregnancy test will be performed if the history is unclear. 2. Participants with a history of connective tissue disorders 3. Participants with active dermatitis, wounds, hypertrophic scars, skin cancer, or skin infection in the treatment area. 4. Participants who have received facial treatments with laser, radiofrequency, thread lifting, botulinum toxin injection, dermal fillers, collagen biostimulators, or platelet-rich plasma within 6 months prior to enrollment. 5. Participants who have used vitamin A or its derivatives within 3 months prior to enrollment. 6. Participants who have received tranexamic acid (oral, topical, or intradermal) within 3 months prior to enrollment. 7. Participants who have undergone chemical peeling within 3 months prior to enrollment. 8. Participants who have used depigmenting agents (e.g., hydroquinone, melasma treatments, or other agents affecting pigmentation as determined by the investigator) within 3 months prior to enrollment. 9. Participants with a history of skin-tightening treatments. 10. Participants who have taken isotretinoin within 6 months prior to enrollment. 11. Participants with a history of malignancy, those currently undergoing cancer treatment, those with immunodeficiency disorders, or any condition deemed by the investigator to pose a safety risk (e.g., epilepsy). 12. Participants with a history of allergy to local anesthetics. 13. Participants with a history of hypertrophic scarring or active dermatologic conditions in the treatment area. 14. Participants with a history of psychiatric disorders. 15. Participants who do not consent to photography for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melanin index Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Mexamter,Erythema index Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Mexamter,Physician improvement scale 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Physician assessment compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Pigmentation average Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Antera 3D,Redness average Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Antera 3D,Brown area Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment VISIA,Red area Baseline, 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment VISIA,Safety 3 months after 1st treatment, 3 months after 2nd treatment, 1, 3 and 6 months after 3rd treatment Adverse events | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed