Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder
- Conditions
- Nevus ZygomaticusSolar Lentigo
- Interventions
- Device: HGM
- Registration Number
- NCT03578315
- Lead Sponsor
- National Taiwan University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nevus zygomaticus HGM 25 Patients with Nevus zygomaticus Solar lentigo HGM 25 Patients with Solar lentigo
- Primary Outcome Measures
Name Time Method 25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by clinical photographs 6 months The primary endpoint is the improvement of target at week 6 scored with a 7-grade. physician global assessment
- Secondary Outcome Measures
Name Time Method 25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by Harmonic Generation Microscopy. 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
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan