Last updated on February 2018

Evaluation of the Cutera Enlighten Laser With Micro-Lens Array (MLA) Handpiece Attachment


Brief description of study

The purpose of this pivotal investigation is to evaluate the efficacy and safety of the Cutera enlighten multi-wavelength 532 nm and 1064 nm Nd:YAG picosecond pulse duration laser and an investigational micro-lens array (MLA) handpiece attachment for improvement of moderate to severe acne scars.

Detailed Study Description

This is an open-label, prospective, multicenter, pivotal study in approximately 15 male or female subjects, age 18 to 65 years who desire laser treatment for the improvement of moderate to severe acne scars. Subjects will receive up to 6 laser treatments, spaced 6 weeks ( 2 weeks) apart with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment. Subjects may undergo a 2mm punch biopsy before, immediately after and up to 72 hours after treatment. Subjects will be contacted by phone 7 days ( 2 days) after their first treatment for follow-up. Subjects will return to the site after all study treatments have been delivered for two follow-up visits: 6 and 12 weeks ( 2 weeks) following their final study treatment and may receive a biopsy per Investigator discretion either at one of these visits or 3 months post initial treatment.

Clinical Study Identifier: NCT03430921

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Cutera Research Center

Brisbane, CA United States
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Recruitment Status: Open


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