Solar Lentigo Clinical Trial
Official title:
Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder
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.
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). |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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 |
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