Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder

NCT03578315 | Completed DMC

• 1 other identifier: 201612113DINC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators demonstrated that in vivo THG microscopy can differentiate Solar lentigos (SL), Nevus zygomaticus(NZ) and normal skin based on the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing an invasive skin biopsy.

Conditions

Solar Lentigo; Nevus Zygomaticus

Keywords

Solar Lentigo; Nevus Zygomaticus; Harmonic Generation Microscopy; In Vivo

Outcome Measures

Primary Outcomes (1)

• 25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by clinical photographs

  The primary endpoint is the improvement of target at week 6 scored with a 7-grade. physician global assessment

  6 months

Secondary Outcomes (1)

• 25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by Harmonic Generation Microscopy.

  1-2 hours per case

Study Arms (2)

Solar lentigo

EXPERIMENTAL

25 Patients with Solar lentigo

Device: HGM

Nevus zygomaticus

EXPERIMENTAL

25 Patients with Nevus zygomaticus

Device: HGM

Interventions

HGM DEVICE

To Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study

Nevus zygomaticus; Solar lentigo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are aged 20 to 85 years at Screening, and can be either sex.
• Subjects are Fitzpatrick skin type III or IV.
• Subjects must have been diagnosed to have solar lentigos or nevus zygomaticus, which are larger than 4 mm in diameter on both sides of the face.

You may not qualify if:

• Subjects have previous treatments on the solar lentigos or nevus zygomaticus.
• Subjects have a history of adverse reaction to laser treatments, including allergy to topical anesthesia application.
• Subjects have a history of chronic inflammatory disorder such as atopic dermatitis on the face.
• Subjects are pregnant or breast feeding.
• Subjects have frequent sun exposure (≥4 hours per day).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Study Officials

• Yi-Hua Liao

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: July 6, 2018
• Study Start: August 1, 2018
• Primary Completion: October 8, 2021
• Study Completion: December 1, 2021
• Last Updated: August 21, 2024

Record last verified: 2024-06

Locations

TW (1)