Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder

August 19, 2024 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A nonrandomized, controlled, split-face comparative study was conducted to compare the efficacy and safety between quality-switched ruby laser (QSRL) and 532-nm picosecond Nd:YAG laser (532-PSNYL for SL, 1064-PSNYL for NZ) in the treatment of solar lentigo clinically and histologically by harmonic generation microscopy (HGM). After baseline photography and in vivo harmonic generation microscopy (HGM) imaging, QSRL and 532-PSNYL or 1064-PSNYL therapy for solar lentigos and nevus zygomaticus on the left and right side of the face, respectively, were performed for each subject. The subjects underwent follow-up assessment at weeks 3 and 6.

Statistical analysis: All data gathered went through decoding and were analyzed by blinded evaluators using SPSS software (version 20.0; IBM, Armonk, NY). All tests were two-sided. A P value of < .05 was considered to be statistically significant.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

1. Main inclusion criteria:

  1. Subjects are aged 20 to 85 years at Screening, and can be either sex.
  2. Subjects are Fitzpatrick skin type III or IV.
  3. 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.

2. Main exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solar lentigo
25 Patients with Solar lentigo
Device: HGM
To Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study
Experimental: Nevus zygomaticus
25 Patients with Nevus zygomaticus
Device: HGM
To Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by clinical photographs
Time Frame: 6 months
The primary endpoint is the improvement of target at week 6 scored with a 7-grade. physician global assessment
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by Harmonic Generation Microscopy.
Time Frame: 1-2 hours per case
The HGM system will be combined to provide the noninvasive microscopic images in SL and NZ sites during each follow-up for pathological diagnosis
1-2 hours per case

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yi-Hua Liao, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

October 8, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 10, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201612113DINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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