Clinical trial NCT04602819: Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma
Official title: Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Keywords: basement membrane
diffractive lens array
melasma
optical coherence tomography
755nm picosecond alexandrite laser
photoaging
vascularization
VISIA®
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2020-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical improvement of melasma
timeFrame: 4 weeks
measure: Improvement of MASI score
timeFrame: 4 weeks
measure: Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index
timeFrame: 4 weeks
measure: Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of subjects with the distinction between melasma and normal skin in tomograms
timeFrame: 1 year
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Chang-Cheng Chang, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: