- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578315
Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder
Study Overview
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yi-Hua Liao
- Phone Number: 0972651558
- Email: yihualiao@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Yi-Hua Liao
- Phone Number: 0972651558
- Email: yihualiao@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
1. Main inclusion criteria:
- Subjects are aged 20 to 85 years at Screening, and can be either sex.
- Subjects are Fitzpatrick skin type III or IV.
- 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:
- Subjects have previous treatments on the solar lentigos or nevus zygomaticus.
- Subjects have a history of adverse reaction to laser treatments, including allergy to topical anesthesia application.
- Subjects have a history of chronic inflammatory disorder such as atopic dermatitis on the face.
- Subjects are pregnant or breast feeding.
- Subjects have frequent sun exposure (≥4 hours per day).
Study Plan
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
|
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
|
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
Investigators
- Principal Investigator: Yi-Hua Liao, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612113DINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Solar Lentigo
-
Cryonove PharmaCEISO; Dermatech; Sefako Makgatho Health Sciences UniversityCompletedSolar Lentigo | Post-inflammatory Hyperpigmentation | Senile LentigoSouth Africa
-
Cryonove PharmaCEISONot yet recruiting
-
Cryonove PharmaCEISO; Dermatech; LTD HEALTHCompletedLentigo Solar | Senile LentigoGeorgia
-
The First Affiliated Hospital with Nanjing Medical...Active, not recruiting
-
CryobeautyCEISOCompleted
-
Cryonove PharmaCEISO; Dermatech; Sefako Makgatho Health Sciences UniversityNot yet recruitingSolar Lentigo | Post Inflammatory Hyperpigmentation | Senile LentigoSouth Africa
-
Cryonove PharmaCEISO; Dermatech; INNOVSOLUTIONCompleted
-
Cryonove PharmaCEISO; Dermatech; INNOVSOLUTIONCompleted
-
CryobeautyCEISOCompleted
-
Cryonove PharmaCEISO; Dermatech; LTD HEALTHCompleted
Clinical Trials on HGM
-
National Taiwan University HospitalCompleted
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanRecruitingHealthy Participants With Different Skin Types and Different Ages | Diseased Participants With Different Skin Types and Different Ages | Participants Suffered From Diabetes With Different Skin Types and Different AgesTaiwan
-
National Taiwan University HospitalUnknownPeripheral Neuropathy | Chemotherapy-induced Peripheral NeuropathyTaiwan
-
Vaxil Therapeutics Ltd.Completed
-
OrienGene Biotechnology Ltd.Beijing Bozhiyin T&S Co., Ltd.; START ShanghaiCompletedMelanoma | Pancreatic Cancer | Lung Cancer | Liver CancerChina
-
GenVivo, Inc.RecruitingHepatocellular Carcinoma | Metastatic CancerPhilippines