Picosecond Laser for Ttreatment of Benign Pigmented Lesions

Syneron Medical

Status: Completed

Conditions: Benign Pigmented Lesions

Treatments: Device: GentleMax system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02146820

DHF13661

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Has Fitzpatrick skin type I-VI
2. 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
3. Is willing to sign an informed consent form to participate in the study
4. 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

1. Is hypersensitive to light exposure
2. Has an active sun tan
3. Has active localized or systemic infection
4. Is taking medication(s) for which sunlight is a contraindication
5. Has a history of squamous cell carcinoma or melanoma
6. Has a history of keloid scarring
7. 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.
8. Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
9. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
10. Is female and pregnant is currently breast feeding or planning a pregnancy during the study period
11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine
12. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 1 patient group

Picosecond Laser System

Experimental group

Treatment:

Device: GentleMax system