Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder

Solar Lentigo Clinical Trial

Official title:

Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578315
• Other study ID #: 201612113DINC
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2020
• Source: National Taiwan University Hospital
• Contact: Yi-Hua Liao
• Phone: 0972651558
• Email: yihualiao[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lentigo
• Nevus Zygomaticus
• Solar Lentigo

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by Harmonic Generation Microscopy.	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