An interventional study of HGM in Solar Lentigo and Nevus Zygomaticus, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's enrollment of 50 is above the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
25 Patients with Solar lentigo
Device: HGM
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
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
Time frame: 6 months
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
Time frame: 1-2 hours per case
Ran from Aug 2018 to primary completion in Oct 2021, 38 months.
Of 11 interventional studies with no phase under Lentigo, half reached primary completion within 2 months of starting (the median); a quarter within 1 and three quarters within 13. This study's 38 months is above that.
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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