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

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

Tracking Information

• First Submitted Date: October 21, 2020
• First Posted Date: October 26, 2020
• Last Update Posted Date: February 11, 2021
• Actual Study Start Date: January 28, 2021
• Estimated Primary Completion Date: February 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2020)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Melasma

Intervention

• 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®.

Study Arms

Experimental: Experimental

Interventions:

• Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens
• Device: ApolloVue® S100 Image System
• Device: Cutometer® dual MPA 580
• Device: VISIA®

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 21, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 25, 2022
• Estimated Primary Completion Date: February 25, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04602819
• Other Study ID Numbers: CMUH109-REC3-125
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Chang Chang Cheng, China Medical University Hospital
• Study Sponsor: China Medical University Hospital
• Collaborators: Apollo Medical Optics, Ltd.

Investigators

• Principal Investigator: Chang-Cheng Chang, M.D., Ph. D.; China Medical University Hospital

• PRS Account: China Medical University Hospital
• Verification Date: February 2021