Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma

Not Applicable

Completed

• Conditions: Melasma

• Registration Number: NCT04602819
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-26
• Study Start: 2021-01-28
• Primary Completion: 2021-02-05
• Study Completion: 2022-02-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, Taiwan