Solar LentigoNCT03578315
Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder
A study testing HGM in people with Solar Lentigo and Nevus Zygomaticus, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Solar Lentigo, Nevus Zygomaticus
- What is being tested?
- HGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Solar Lentigo, Nevus Zygomaticus
- Being tested
- HGM
- Keywords
- Solar Lentigo, Nevus Zygomaticus, Harmonic Generation Microscopy, In Vivo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGMDevice
To Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study
| Study group | Role | What they receive |
|---|---|---|
| Solar lentigo | Experimental | 25 Patients with Solar lentigo Receives: Device: HGM |
| Nevus zygomaticus | Experimental | 25 Patients with Nevus zygomaticus Receives: Device: HGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 1-2 hours per case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Aug 2018
- Primary completion8 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentigoStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hua Liao, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578315
- Sponsor's protocol ID
- 201612113DINC
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Harmonic Generation Microscopy for Treatment Assessment of Cutaneous Pigmentary Disorder
- ClinicalTrials.gov ID
- NCT03578315
- Acronym / sponsor ID
- 201612113DINC
- Conditions
- Solar Lentigo, Nevus Zygomaticus
- Keywords
- Solar Lentigo, Nevus Zygomaticus, Harmonic Generation Microscopy, In Vivo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solar lentigo | Experimental | Device: HGM25 Patients with Solar lentigo |
| Nevus zygomaticus | Experimental | Device: HGM25 Patients with Nevus zygomaticus |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGMTo Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study | Device | Nevus zygomaticus, Solar lentigo |
Primary outcome
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
1 secondary outcome
25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by Harmonic Generation Microscopy.
Time frame: 1-2 hours per case
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Solar Lentigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hua Liao principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGM in people with Solar Lentigo and Nevus Zygomaticus, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25 participants with Solar Lentigo and 25 participants with Nevus zygomaticus as assessed by clinical photographs (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.