Nd:YAG picosecond laser treatment for melanocytic naevi

JRCT ID: jRCTs052230007

Registered date:11/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: melanocytic naevi
• Date of first enrollment: 11/04/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

The participant will be administered with 532nmNd:YAG picosecond lazer
by the PQX pico lazer system into individual melanocytic naevi presented head, face, trunk, arm or leg by assigning the lesion. The treatment course includes maximum 5 treatment sessions conducted with a 4-week interval.

Outcome(s)

• Primary Outcome: Overall judgment of therapeutic efficacy
• Secondary Outcome: time-to-treatment-failure, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 1month old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Male or female More than 1 month old. melanocytic naevi presented on the head, face, trunk, arm or leg.,who was diagnosed by skin biopsy.

Exclude criteria

Patient with having severe underlying disease, pre
gnancy or lactation, Photosensivity, Porphyria, cardiac conduction
disturbance, allergic conditioned, local anesthesia
allergies, vascular or bleeding disorders, treatedwith anticoagulant therapy, autoimmune disease, t
reated with immunosuppressive therapy, keloid sc
ar formation, hypertrophic scar formation, maligna
nt skin tumor, pigment anomaly, inflammatory dise
ase that a symptom may aggravate in irritation by
a treatment, medical history of herpesvirus infecti
on. Invasive aesthetic treatments or surgery on the navi
within 6 months prior to the study enrollment.
Physical or chemical aesthetic treatments on the naevi within 3
month prior to the study enrollment.

Related Information

• Primary Sponsor: Yuki Yamamoto
• Secondary Sponsor: Kayo Kunimoto
• Source(s) of Monetary Support: JMEC Co., Ltd.