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

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:

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens; Device: ApolloVue® S100 Image System; Device: Cutometer® dual MPA 580; Device: VISIA®

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 404332
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental

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.; Device: ApolloVue® S100 Image System; 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.; Other Names: 510(K) Number: K201552 (class II); Device: Cutometer® 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.; Device: 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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Apollo Medical Optics, Ltd
• Investigators: Principal Investigator: Chang-Cheng Chang, M.D., Ph. D., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: melasma; optical coherence tomography; photoaging; vascularization; basement membrane; diffractive lens array; 755nm picosecond alexandrite laser; VISIA®
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: CMUH109-REC3-125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No