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

NCT ID: NCT04602819

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2022-02-10

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.

Conditions

Melasma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

PicoSure 755nm picosecond alexandrite laser with diffractive lens

Intervention Type: 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.

ApolloVue® S100 Image System

Intervention Type: 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.

Cutometer® dual MPA 580

Intervention Type: 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.

VISIA®

Intervention Type: 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®.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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®.

Intervention Type: DEVICE

Other Intervention Names

510(K) Number: K201552 (class II)

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apollo Medical Optics, Ltd

INDUSTRY

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang Chang Cheng

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Cheng Chang, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 37365922 (View on PubMed)

Other Identifiers

CMUH109-REC3-125

Identifier Type: -

Identifier Source: org_study_id