MelasmaNCT04602819
Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma
A study testing PicoSure 755nm picosecond alexandrite laser with diffractive lens, ApolloVue® S100 Image System and Cutometer® dual MPA 580 in people with Melasma, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Background Melasma is a commonly acquired hypermelanosis that affects facial sun exposed areas, most commonly in Asians and other darker skin type females. Recent evidence has demonstrated melasma to be a photoaging disorder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- PicoSure 755nm picosecond alexandrite laser with diffractive lens, ApolloVue® S100 Image System and Cutometer® dual MPA 580
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jan 2021to 10 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign a written inform consent form
- Adults over the age of 20.
- Patients with melasma on their faces.
Who cannot join
- have received any cosmetic treatments, e.g. laser, pulsed light, and chemical peels within six months before participating the trial.
- Have taken oral contraceptives or received hormone therapy within one year before participating the trial.
- Has other pigmented diseases or inflammatory diseases on face.
- Are pregnant or breastfeeding.
- Has conditions with poor wound healing, keloids or photosensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma
Background Melasma is a commonly acquired hypermelanosis that affects facial sun exposed areas, most commonly in Asians and other darker skin type females. Recent evidence has demonstrated melasma to be a photoaging disorder. The histological findings of melasma are similar to photoaging and include solar elastosis, increased mast cells and sebaceous glands, as well as increased vascularization. Pendulous active melanocytes with weakened basal membranes, and changes in nuclear morphology and chromatin texture of adjacent basal keratinocytes also seemed to be a characteristic feature of melasma.
Objectives:
Read more
To compare the difference of photoaging features of melasma skin and normal skin by optical coherence tomography (ApolloVue® S100 Image System, a 510(K) class II medical device) and reversal of photoaing features by 755nm picosecond alexandrite laser with diffractive lens.
Methodology:
We enroll 20 adults with facial melasma. The patients received 755nm picosecond alexandrite laser with diffractive lens array over whole face at W0, W4, and W8. Evaluation with VISIA, optical coherence tomography, Cutometer MPA580 at W4, W8, W12. All the patients will be instructed with use of moisturizer, gentle cleaning, and sunscreen use.
Anticipated results and applications:
This study expects to
- understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
- Set evidence based guidance for melasma treatment and set the protocol or clinical path.
- Conditions
- Melasma
- Being tested
- PicoSure 755nm picosecond alexandrite laser with diffractive lens, ApolloVue® S100 Image System, Cutometer® dual MPA 580, VISIA®
- Keywords
- basement membrane, diffractive lens array, melasma, optical coherence tomography, 755nm picosecond alexandrite laser, photoaging, vascularization, VISIA®
- Medical subject headings
- Melanosis, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicoSure 755nm picosecond alexandrite laser with diffractive lensDevice
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
ApolloVue® S100 Image SystemDevice
Also called 510(K) Number: K201552 (class II)
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography.
Cutometer® dual MPA 580Device
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the Cutometer® dual MPA 580.
VISIA®Device
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens; Device: ApolloVue® S100 Image System; Device: Cutometer® dual MPA 580; Device: VISIA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of melasma
Clinical improvement of melasma after picosecond laser treatment will be assessed by both physician and patient at week 0, week 4, week 8, and week 12.
Measured: 4 weeks
Improvement of MASI score
Improvement of melasma after picosecond laser treatment will be assessed using MASI score that will be calculated according to the image taken by VISIA at week 0, week 4, week 8, and week 12.
Measured: 4 weeks
Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index
Improvement of melasma after picosecond laser treatment will be assessed using Cutometer® MPA 580 at week 0, week 4, week 8, and week 12.
Measured: 4 weeks
Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms
Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning melasma at study completion.
Measured: 4 weeks
Secondary outcomes (1)
Number of subjects with the distinction between melasma and normal skin in tomograms
Number of subjects with the distinction between melasma and normal skin in tomograms will be compared to that with no distinction to verify the specific diseases that can be distinguished from others by the OCT at study completion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start28 Jan 2021
- Primary completion5 Feb 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by China Medical 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Apollo Medical Optics, Ltd
- Responsible party
- Principal investigator, Chang Chang Cheng, China Medical University Hospital
- Investigators
- Chang-Cheng Chang, M.D., Ph. D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602819
- Sponsor's protocol ID
- CMUH109-REC3-125
- Status last verified
- Jul 2022
- First submitted
- 21 Oct 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang YJ, Chang CC, Wu YH, Huang L, Shen JW, Lu ME, Chiang HM, Lin BS. Adaptability of melanocytes post ultraviolet stimulation in patients with melasma. Lasers Surg Med. 2023 Sep;55(7):680-689. doi: 10.1002/lsm.23699. Epub 2023 Jun 27.
PubMed 37365922
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma
- ClinicalTrials.gov ID
- NCT04602819
- Acronym / sponsor ID
- CMUH109-REC3-125
- Conditions
- Melasma
- Keywords
- basement membrane, diffractive lens array, melasma, optical coherence tomography, 755nm picosecond alexandrite laser, photoaging, vascularization, VISIA®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Apollo Medical Optics, Ltd
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 26 Oct 2020 (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.
Background Melasma is a commonly acquired hypermelanosis that affects facial sun exposed areas, most commonly in Asians and other darker skin type females. Recent evidence has demonstrated melasma to be a photoaging disorder. The histological findings of melasma are similar to photoaging and include solar elastosis, increased mast cells and sebaceous glands, as well as increased vascularization. Pendulous active melanocytes with weakened basal membranes, and changes in nuclear morphology and chromatin texture of adjacent basal keratinocytes also seemed to be a characteristic feature of melasma.
Objectives:
To compare the difference of photoaging features of melasma skin and normal skin by optical coherence tomography (ApolloVue® S100 Image System, a 510(K) class II medical device) and reversal of photoaing features by 755nm picosecond alexandrite laser with diffractive lens.
Methodology:
We enroll 20 adults with facial melasma. The patients received 755nm picosecond alexandrite laser with diffractive lens array over whole face at W0, W4, and W8. Evaluation with VISIA, optical coherence tomography, Cutometer MPA580 at W4, W8, W12. All the patients will be instructed with use of moisturizer, gentle cleaning, and sunscreen use.
Anticipated results and applications:
This study expects to
- understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
- Set evidence based guidance for melasma treatment and set the protocol or clinical path.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens, Device: ApolloVue® S100 Image System, Device: Cutometer® dual MPA 580, Device: VISIA® |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to sign a written inform consent form
- Adults over the age of 20.
- Patients with melasma on their faces.
Key exclusion criteria (5 listed)
- have received any cosmetic treatments, e.g. laser, pulsed light, and chemical peels within six months before participating the trial.
- Have taken oral contraceptives or received hormone therapy within one year before participating the trial.
- Has other pigmented diseases or inflammatory diseases on face.
- Are pregnant or breastfeeding.
- Has conditions with poor wound healing, keloids or photosensitivity.
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 |
|---|---|---|
| PicoSure 755nm picosecond alexandrite laser with diffractive lensUnderstand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods. | Device | Experimental |
| ApolloVue® S100 Image SystemAlso: 510(K) Number: K201552 (class II)Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography. | Device | Experimental |
| Cutometer® dual MPA 580Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the Cutometer® dual MPA 580. | Device | Experimental |
| VISIA®Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®. | Device | Experimental |
Primary outcome
Clinical improvement of melasma
Time frame: 4 weeks
Clinical improvement of melasma after picosecond laser treatment will be assessed by both physician and patient at week 0, week 4, week 8, and week 12.
Improvement of MASI score
Time frame: 4 weeks
Improvement of melasma after picosecond laser treatment will be assessed using MASI score that will be calculated according to the image taken by VISIA at week 0, week 4, week 8, and week 12.
Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index
Time frame: 4 weeks
Improvement of melasma after picosecond laser treatment will be assessed using Cutometer® MPA 580 at week 0, week 4, week 8, and week 12.
Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms
Time frame: 4 weeks
Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning melasma at study completion.
1 secondary outcome
Number of subjects with the distinction between melasma and normal skin in tomograms
Time frame: 1 year
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 20 Jul 2022.
- Derived from this study: PubMed 37365922Wang YJ, Chang CC, Wu YH, Huang L, Shen JW, Lu ME, Chiang HM, Lin BS. Adaptability of melanocytes post ultraviolet stimulation in patients with melasma. Lasers Surg Med. 2023 Sep;55(7):680-689. doi: 10.1002/lsm.23699. Epub 2023 Jun 27.
- Individual participant dataSharing planned: No
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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.
Chang-Cheng Chang, M.D., Ph. D. principal investigator
China Medical 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 PicoSure 755nm picosecond alexandrite laser with diffractive lens, ApolloVue® S100 Image System and Cutometer® dual MPA 580 in people with Melasma, run by China Medical 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?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 20 Jul 2022. 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?
Clinical improvement of melasma (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602819, which also lists 1 linked publication.
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 20 Jul 2022.