An interventional study of PicoSure Pro Device and PicoSure Device in Wrinkle, Acne Scars and Benign Epidermal Pigmented Lesions, sponsored by Cynosure, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment
The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 100 subjects will be enrolled at up to 4 study centers. Subjects will be enrolled into one of the 3 groups; Group A, Group B, or Group C.
Exclusion Criteria:
Cautionary Criteria:
Subjects will receive a split face treatment with the PicoSure Pro and/or PicoSure devices using different device settings on each half of the face.
Device: PicoSure Pro Device · Device: PicoSure Device
Subjects will receive a full face treatment with the PicoSure Pro or PicoSure device and will use topical cosmeceuticals on only half of their face.
Device: PicoSure Pro Device · Device: PicoSure Device · Drug: Topical Cosmeceuticals
Subjects will receive treatments with the PicoSure Pro or PicoSure device on multiple areas of the body such as the face, décolletage, back, legs, arms, and hands.
Device: PicoSure Pro Device · Device: PicoSure Device
This device will be used for up to 4 treatments over the designated areas.
This device will be used for up to 4 treatments over the designated areas.
Topical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area.
Grading of Pre-Treatment vs. Follow Up Images
The investigator will grade the improvement they noticed between the baseline image and the follow up image based on the Global Aesthetic Improvement Scale (GAIS), which ranges from 1-5 as follows: Very Much Improved (1), Much Improved (2), Improved (3), No Change (4), Worse (5).
Time frame: 30 day follow up
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Cynosure, Inc.