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

NCT04602819 | Completed DMC

• 1 other identifier: CMUH109-REC3-125
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 2.Set evidence based guidance for melasma treatment and set the protocol or clinical path.

Conditions

Melasma

Keywords

basement membrane; diffractive lens array; melasma; optical coherence tomography; 755nm picosecond alexandrite laser; photoaging; vascularization; VISIA®

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of subjects with the distinction between melasma and normal skin in tomograms

  1 year

Study Arms (1)

Experimental

EXPERIMENTAL

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

Interventions

PicoSure 755nm picosecond alexandrite laser with diffractive lens DEVICE

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.

Experimental

ApolloVue® S100 Image System DEVICE

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.

Also known as: 510(K) Number: K201552 (class II)

Experimental

Cutometer® dual MPA 580 DEVICE

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.

Experimental

VISIA® DEVICE

Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®.

Experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign a written inform consent form
• Adults over the age of 20.
• Patients with melasma on their faces.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Apollo Medical Optics, Ltd: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404332, Taiwan

Location

Related Publications (1)

• Wang YJ, Chang CC, Wu YH, Huang L, Shen JW, Lu ME, Chiang HM, Lin BS. Adaptability of melanocytes post ultraviolet stimulation in patients with melasma. Lasers Surg Med. 2023 Sep;55(7):680-689. doi: 10.1002/lsm.23699. Epub 2023 Jun 27.

  PMID: 37365922 DERIVED

MeSH Terms

Conditions

Melanosis; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chang-Cheng Chang, M.D., Ph. D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: January 28, 2021
• Primary Completion: February 5, 2021
• Study Completion: February 10, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)