UnknownNot Applicable

Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars

United States53 participantsStarted 2015-05-23

Plain-language summary

Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Healthy female and male subjects between 18 to 75 years of age
✓. Has Fitzpatrick skin type I-VI
✓. Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement
✓. Have bilateral moderate to severe facial acne scars
✓. Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
✓. 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
✕. Active sun tan in facial area
✕. 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
✕. Is taking medication(s) for which sunlight is a contraindication
✕. Has a history of squamous cell carcinoma or melanoma
✕. History of keloid scarring, abnormal wound healing and / or prone to bruising
✕. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders

What they're measuring

Efficacy of the PicoWayTM treatment

Timeframe: from day 0 up to 13 months

Trial details

NCT IDNCT02592993

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Acne Scars - Mixed Atrophic and Hypertrophic trials