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

Melasma Clinical Trial

Official title:

Photoaging Reversing After Picosecond Laser With Diffractive Focus Lens Assessed by Cellular Resolution Optical Coherent Tomography in Asian Patient With Melasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602819
• Other study ID #: CMUH109-REC3-125
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: July 2022
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2022
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanosis
• 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.
• 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.
• 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.
• 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®.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung City

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Apollo Medical Optics, Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	1 year