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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 : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd.
Information provided by (Responsible Party):
Chang Chang Cheng, China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE October 21, 2020
First Posted Date  ICMJE October 26, 2020
Last Update Posted Date October 26, 2020
Estimated Study Start Date  ICMJE October 21, 2020
Estimated Primary Completion Date February 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photoaging Reversing After Picosecond Laser With DLA Assessed by Cellular Resolution OCT in Asian Patient With Melasma
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melasma
Intervention  ICMJE 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.
Other Names:
  • ApolloVue® S100 Image System (Cellular resolution optical coherence tomography)
  • Cutometer® dual MPA 580
  • VISIA®
Study Arms  ICMJE Experimental: Experimental
Intervention: Device: PicoSure 755nm picosecond alexandrite laser with diffractive lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 21, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 25, 2022
Estimated Primary Completion Date February 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chang-Cheng Chang, M.D., Ph. D. 886-04-22052121 changcc1975@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04602819
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Chang Chang Cheng, China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Apollo Medical Optics, Ltd.
Investigators  ICMJE
Principal Investigator: Chang-Cheng Chang, M.D., Ph. D. China Medical University Hospital
PRS Account China Medical University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP