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

C

China Medical University

Status

Completed

Conditions

Melasma

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04602819
CMUH109-REC3-125

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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