Performance of PicoWayTM Picosecond Fractional Laser for Acne Scars
Status unconfirmed · Not applicable
Conditions studied: Acne Scars - Mixed Atrophic and Hypertrophic
In brief
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.
Key facts
- Study ID
- NCT02592993
- Run by
- Syneron Medical
- People needed
- 53
- Starts
- 2015-05-23
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
- 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
- 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.
- A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator'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
- Dr. Jerome M. Garden — Chicago, Illinois, United States
- New York Laser & Skin Care — New York, New York, United States
- Dr. Eric F. Bernstein — Ardmore, Pennsylvania, United States
Full record on ClinicalTrials.gov
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