Study for the RevLite Laser System for Facial Solar Lentigines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of the Revlite Laser System for treatment of facial solar lentigines

Detailed Description
-----------------
Prospective facial study using the revlite laser to treat pigmentation caused by sun damage.

Official Title
-----------------
Study for the RevLite Laser System for Facial Solar Lentigines

Conditions
-----------------
Facial Solar Lentigines

Intervention / Treatment
-----------------
* Device: Revlite Laser System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a healthy male or female between 18 and 60 years old. Is Fitzpatrick Skin types I-III Is willing to consent to participate in 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. Has clinically determined mild to severe facial mottled pigmentation (solar lentigines) on the face. Exclusion Criteria: Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period. Is hypersensitive to light exposure OR takes photo sensitized medication. Has active or localized systemic infections. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}). Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study. Has used Accutane within 6 months prior to enrollment. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate). Has a history of keloids. Has evidence of compromised wound healing. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient receives a single wavelength treatment on one side of their face, and a double wavelength on the other side of their face.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revlite Laser System- Single Wavelength<br>Revlite Laser System- 1064nm wavelength will be used on half of the face. | Device: Revlite Laser System<br>* Revlite Laser System for the Treatment of Facial Solar Lentigines<br>|
| Experimental: Revlite Laser System- Dual Wavelength<br>Revlite Laser System- treatment will consist of 1064 nm and 532 nm wavelengths on half of the face. | Device: Revlite Laser System<br>* Revlite Laser System for the Treatment of Facial Solar Lentigines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale | Photos taken at baseline will be compared to photos taken 1 month post last treatment to assess the level of improvement using the Global Aesthetic Improvement Scale. This evaluation is blinded. This scale ranges from -1 to 3, where -1 is worsened, 0 is no change, 1 is improved, 2 is much improved, and 3 is very much improved. | 1 month post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Satisfaction Questionnaire | The satisfaction is on a scale ranging from extremely satisfied (6) to extremely dissatisfied (1). | 1 month post last treatment |