A Single-Center 2-Arm Study for Lentigines on the Hands

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness and safety of two laser systems for improvement of lentigines on the hands.

Detailed Description
-----------------
The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots) on the hands.

Official Title
-----------------
A Single-Center 2-Arm Study of the Enlighten and Excel V Laser for Lentigines on the Hands

Conditions
-----------------
Lentigines

Intervention / Treatment
-----------------
* Device: Enlighten Laser
* Device: Excel V Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or Male, 30-90 years of age (inclusive). Fitzpatrick Skin Type I - III. Desires non-invasive and non-ablative treatment of lentigines on the hand(s). Have 4 or more lentigines on the hand(s). Subject must be able to read, understand and sign the Informed Consent Form. Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes. Agree to not undergo any other procedure(s) for treatment of lentigines during the study, including but not limited to chemical peel, laser and light based device treatment, and home-use device treatment. Agree to not undergo any injection of botulinum toxin, collagen, hyaluronic acid filler or other dermal filler to the treatment area during the study. Exclusion Criteria: Participation in a clinical trial of another device or drug in the target area within 6 months prior to enrollment or during the study. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery. Systemic use of retinoid, such as isotretinoin, within 6 months of study participation. Use of topical medications on the hands, such as antibiotics, benzoyl peroxide, retinoids (isotretinoin), corticosteroids, hydroquinone, or products containing dihydroxyacetone or alpha-hydroxy with concentration > 8%, within 1 month of participation. History of malignant tumors in the target area. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles. Pregnant. Having an infection, dermatitis, or a rash in the treatment area. History of keloid scarring, hypertrophic scarring or of abnormal wound healing. Any use of medication that is known to increase sensitivity to light according to investigator's discretion. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systematic therapy that could interfere with this research study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enlighten Laser<br>12 subjects will receive treatment the Enlighten laser. | Device: Enlighten Laser<br> <br> |
| Active Comparator: Excel V Laser<br>12 subjects will receive treatment with the Excel V laser. | Device: Excel V Laser<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Reduction in the Number of Hand Lentigines as Assessed by Blinded Reviewers. |  | 4 weeks post-final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment Score of the Overall Appearance of the Hands | Degree of improvement in the overall appearance of the hands as assessed by blinded reviewers using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change Higher scores indicate better outcomes | 4 weeks post final treatment | 
| Physician's Global Assessment Score of Skin Texture of the Hands | Degree of improvement in the Skin Texture of the hands as assessed using the Physician's Global Assessment scale: 4=Very Significant Improvement,3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement and 0=No Change. Higher scores indicate better outcomes | 4 weeks post final treatment | 
| Subject Satisfaction | Subject-completed questionnaire to rate their level of satisfaction with the laser treatment outcome | 4 weeks post final treatment |