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

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PicoSure 755nm picosecond alexandrite laser with diffractive lens
ApolloVue® S100 Image System
Cutometer® dual MPA 580
VISIA®
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring basement membrane, diffractive lens array, melasma, optical coherence tomography, 755nm picosecond alexandrite laser, photoaging, vascularization, VISIA®

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 21, 2020
Last Updated
July 19, 2022
Sponsor
China Medical University Hospital
Collaborators
Apollo Medical Optics, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04602819
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
February 5, 2021 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
Apollo Medical Optics, Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
basement membrane, diffractive lens array, melasma, optical coherence tomography, 755nm picosecond alexandrite laser, photoaging, vascularization, VISIA®

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PicoSure 755nm picosecond alexandrite laser with diffractive lens
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ApolloVue® S100 Image System
Other Intervention Name(s)
510(K) Number: K201552 (class II)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cutometer® dual MPA 580
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
VISIA®
Intervention Description
Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®.
Primary Outcome Measure Information:
Title
Clinical improvement of melasma
Description
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.
Time Frame
4 weeks
Title
Improvement of MASI score
Description
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.
Time Frame
4 weeks
Title
Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index
Description
Improvement of melasma after picosecond laser treatment will be assessed using Cutometer® MPA 580 at week 0, week 4, week 8, and week 12.
Time Frame
4 weeks
Title
Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with the distinction between melasma and normal skin in tomograms
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Cheng Chang, M.D., Ph. D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404332
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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