Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography

July 18, 2022 updated by: Taipei Veterans General Hospital, Taiwan

In recent years, with the maturity of laser technology, laser therapy is one of the popular options for the treatment of pigment diseases. The absorption spectrum of melanin ranges from 300 to 1,000 nm. In past studies, the 532 nm Q-switched Nd:YAG laser is effective for the treatment of superficial melanin. But there are still some side effects in laser treatment, such as post-inflammation pigmentation (PIH), depigmentation, skin redness, etc., and PIH is particularly likely to occur on darker skin. However, there is still no good evidence as to what factors or laser treatments can cause PIH.

Therefore, in this study, we will use ApolloVue® S100 Image System (ApolloVue® S100 Image System is a medical device class II) to scan before and after skin of laser treatment to observe the changes in the skin condition. By observing and analyzing these changes, as a evaluation of predictors or prognostic factors after laser treatment and whether PIH will occur.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Beitou District
      • Taipei city, Beitou District, Taiwan, 11217
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≧ 20
  • Both gender are accepted
  • Subject with pigmented diseases
  • The pigmented lesions which participating the trial were not treated in the last 12 months
  • Accepts not to expose the face to sunlight or artificial UV rays during the study
  • Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
  • During the trial period, willing to use the maintenance and sunscreen products provided in this trial for care

Exclusion Criteria:

  • Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
  • Has any condition which, in the investigator's opinion, would make it unsafe for participating in this research study
  • Has systemic skin disorders or infections
  • Is enrolled or accepted other investigational drug or medical device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Epidermal pigmented lesion
Device: Laser
The device will be used to do Laser treatment. To compare the therapeutic effect to laser treatment before and post treatment for 14 and 60 days.
Device: ApolloVue® S100 Image System
The device is an in vivo non-invasive optical coherence tomography and will be used to obtain OCT images before and after laser treatment of skin.
Device: VISIA®
The device is skin analysis system and will be used to obtain before and after images of laser treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static Physician's Global Assessment (PGA)
Time Frame: one and a half years

Static PGA is often used to evaluate disease severity of psoriasis. In recent years, this evaluation index has also been applied to pigmented diseases, such as solar lentigo, melasma, and vitiligo. In this trial, Static PGA divides the severity of pigmented diseases into 0~8.

  1. 0: Extremely lighter than pigment of surrounding skin (completely depigmented)
  2. 1: markedly lighter than pigment of surrounding skin
  3. 2: moderately lighter than pigment of surrounding skin
  4. 3: slightly lighter than pigment of surrounding skin
  5. 4: equal with pigment of surrounding skin
  6. 5: slightly darker than pigment of surrounding skin
  7. 6: moderately darker than pigment of surrounding skin
  8. 7: markedly darker than pigment of surrounding skin
  9. 8: extremely darker than pigment of surrounding skin
one and a half years
Dynamic Physician's Global Assessment (PGA)
Time Frame: one and a half years

Dynamic PGA is often used to evaluate the degree of improvement after treatment of the disease. In this trial, Dynamic PGA evaluates the degree of improvement after comparing with the state before treatment (baseline). The degree of improvement is divided into 0~5.

  1. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement
  2. 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement
  3. 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement
  4. 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement
  5. 4: no change in cosmetic appearance from baseline
  6. 5: cosmetic appearance worse than at baseline
one and a half years
Subject satisfaction
Time Frame: one and a half years

During the two follow-up visits after treatment, subjects will evaluate their satisfaction after treatment. In this trial, this evaluation form will be divided into 0 to 5 points according to the degree of improvement.

  1. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement
  2. 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement
  3. 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement
  4. 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement
  5. 4: no change in cosmetic appearance from baseline
  6. 5: cosmetic appearance worse than at baseline
one and a half years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

Apollo Medical Optics, Ltd

Investigators

  • Principal Investigator: Cheng-Yuan Li, M.D., Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-08-006C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Pigmented Lesions

Clinical Trials on Laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe