Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma
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|ClinicalTrials.gov Identifier: NCT04602819|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
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.
To compare the difference of photoaging features of melasma skin and normal skin by optical coherence tomography and reversal of photoaing features by 755nm picosecond alexandrite laser with diffractive lens.
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.
|Condition or disease||Intervention/treatment||Phase|
|Melasma||Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma|
|Estimated Study Start Date :||October 21, 2020|
|Estimated Primary Completion Date :||February 25, 2022|
|Estimated Study Completion Date :||February 25, 2022|
Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens
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.
- 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.
- Number of subjects with the distinction between melasma and normal skin in tomograms [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602819
|Contact: Chang-Cheng Chang, M.D., Ph. D.||firstname.lastname@example.org|
|China Medical University Hospital||Recruiting|
|Taichung City, Taiwan, 404332|
|Principal Investigator:||Chang-Cheng Chang, M.D., Ph. D.||China Medical University Hospital|