785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Status unconfirmed · Not applicable

Conditions studied: Benign Pigmented Lesions

In brief

This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.

Key facts

Study ID

NCT02891239

Run by

Syneron Medical

People needed

60

Starts

2016-09-01

Expected to finish

2017-09-01

Last updated by the study team

2016-09-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy female and male subjects between 18 to 70 years of age
• Fitzpatrick skin type I-VI
• Presence of unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, Nevis of Ota, Nevus of Ito and hyperpigmentation. Multiple lesions can be treated.
• Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions.
• Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked).
• For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
• Informed consent process is completed and subject consent is signed.

You may not qualify if…

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
• Hypersensitivity to light exposure
• Taking medication(s) for which sunlight is a contraindication
• Active sun tan
• Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
• History of squamous cell carcinoma or melanoma
• History of keloid scarring, abnormal wound healing and / or prone to bruising
• Use of 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
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
• Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
• Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
• 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
• As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Where it is running

• Syneron Candela Institute for Education Clinic — Wayland, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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