Expired Study
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San Francisco, California 94115


Purpose:

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


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02146820


Primary Contact:

Study Director
Shlomit Mann
Syneron Medical Ltd.


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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