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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Benign Pigmented Lesions

Intervention / Treatment
-----------------
* Device: Laser
* Device: ApolloVue® S100 Image System
* Device: VISIA®


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Epidermal pigmented lesion | Device: Laser<br>* 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.<br>Device: ApolloVue® S100 Image System<br>* 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.<br>Device: VISIA®<br>* The device is skin analysis system and will be used to obtain before and after images of laser treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Physician's Global Assessment (PGA) | 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. 0: Extremely lighter than pigment of surrounding skin (completely depigmented) 1: markedly lighter than pigment of surrounding skin 2: moderately lighter than pigment of surrounding skin 3: slightly lighter than pigment of surrounding skin 4: equal with pigment of surrounding skin 5: slightly darker than pigment of surrounding skin 6: moderately darker than pigment of surrounding skin 7: markedly darker than pigment of surrounding skin 8: extremely darker than pigment of surrounding skin | one and a half years | 
| Dynamic Physician's Global Assessment (PGA) | 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. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement 4: no change in cosmetic appearance from baseline 5: cosmetic appearance worse than at baseline | one and a half years | 
| Subject satisfaction | 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. 0: completely cleared of undesired pigment; no evidence of cosmetic deficit remaining; 100% improvement 1: significant clearance of undesired pigment; slight evidence of cosmetic deficit remaining; about 75% improvement 2: moderate clearance of undesired pigment; moderate evidence of cosmetic deficit remaining; about 50% improvement 3: slight clearance of undesired pigment; marked evidence of cosmetic deficit remaining; about 25% improvement 4: no change in cosmetic appearance from baseline 5: cosmetic appearance worse than at baseline | one and a half years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical Coherence Tomograohy, Non-invasive image system, Cellular level resolution, Full-Field OCT, Hyperpigmentation