Picosecond Laser for Ttreatment of Benign Pigmented Lesions

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Pico laser is effective and safe in the treatment of benign pigmented lesions.

Detailed Description
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The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

Official Title
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LASER TREATMENT OF BENIGN PIGMENTED LESIONS WITH A DUAL WAVELENGTH PICOSECOND LASER

Conditions
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Benign Pigmented Lesions

Intervention / Treatment
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* Device: GentleMax system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has Fitzpatrick skin type I-VI Has unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, New of Ota, Nevus of Ito, and hyperpigmentation, and wishes to undergo laser treatments to remove them Is willing to sign an informed consent form 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 Exclusion Criteria: Is hypersensitive to light exposure Has an active sun tan Has active localized or systemic infection Is taking medication(s) for which sunlight is a contraindication Has a history of squamous cell carcinoma or melanoma Has a history of keloid scarring Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness. Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications Is female and pregnant is currently breast feeding or planning a pregnancy during the study period Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picosecond Laser System<br> | Device: GentleMax system<br>* Picosecond Laser System for the Treatment of Pigmented Lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global percentage of pigment clearance | Global percentage of pigment clearance evaluated by blinded observers using post treatment photographs compared to baseline photographs. | 3 months post the final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | Adverse events will be evaluated immediately after and before each subsequent laser treatment and will be based on the incidence and severity of side effects caused by the laser treatments. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pigmented Lesions, Skin Pigment, Picosecond Laser, Syneron