Picosecond Laser for Ttreatment of Benign Pigmented Lesions

Completed · Not applicable

Conditions studied: Benign Pigmented Lesions

In brief

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

Key facts

Study ID

NCT02146820

Run by

Syneron Medical

People needed

60

Starts

2013-12-01

Last updated by the study team

2015-06-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Laser and Cosmetic Dermatology — San Francisco, California, United States
• Hong Kong Dermatology and Laser Centre — Hong Kong, China

Full record on ClinicalTrials.gov

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