785nm Picosecond Laser for Treatment of Benign Pigmented Lesions (NCT02891239) | Clinical Trial Compass
UnknownNot Applicable
785nm Picosecond Laser for Treatment of Benign Pigmented Lesions
United States60 participantsStarted 2016-09
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Healthy female and male subjects between 18 to 70 years of age
✓. 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.
Exclusion criteria
✕. 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
. 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