Melasma
Conditions
Keywords
basement membrane, diffractive lens array, melasma, optical coherence tomography, 755nm picosecond alexandrite laser, photoaging, vascularization, VISIA®
Brief 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. 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 1. 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. 2. Set evidence based guidance for melasma treatment and set the protocol or clinical path.
Interventions
DEVICEPicoSure 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.
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.
DEVICECutometer® dual MPA 580
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.
DEVICEVISIA®
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®.
Sponsors
Apollo Medical Optics, Ltd
China Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to sign a written inform consent form * Adults over the age of 20. * Patients with melasma on their faces.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement of melasma | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with the distinction between melasma and normal skin in tomograms | 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. |
Countries
Taiwan
Outcome results
None listed