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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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ClinicalTrials.gov Identifier: NCT04602819
Recruitment Status : Active, not recruiting
First Posted : October 26, 2020
Last Update Posted : February 11, 2021
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd.
Information provided by (Responsible Party):
Chang Chang Cheng, China Medical University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melasma Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens Device: ApolloVue® S100 Image System Device: Cutometer® dual MPA 580 Device: VISIA® Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : February 25, 2022
Estimated Study Completion Date : February 25, 2022
Arms and Interventions
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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 Name: 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®.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical improvement of melasma [ Time Frame: 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.

  2. Improvement of MASI score [ Time Frame: 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.

  3. Improvement of hydration, TEWL, viscoelasticity, or melanin and erythema index [ Time Frame: 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.

  4. Number of subjects with clear tissue characteristics of melasma and/or normal skin in tomograms [ Time Frame: 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 Outcome Measures :
  1. Number of subjects with the distinction between melasma and normal skin in tomograms [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602819


Locations
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Taiwan
China Medical University Hospital
Taichung City, Taiwan, 404332
Sponsors and Collaborators
China Medical University Hospital
Apollo Medical Optics, Ltd.
Investigators
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Principal Investigator: Chang-Cheng Chang, M.D., Ph. D. China Medical University Hospital
More Information
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Responsible Party: Chang Chang Cheng, Director, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04602819    
Other Study ID Numbers: CMUH109-REC3-125
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Chang Cheng, China Medical University Hospital:
basement membrane
diffractive lens array
melasma
optical coherence tomography
 755nm picosecond alexandrite laser
photoaging
vascularization
VISIA®
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases