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Clinical Trial Summary

The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin photo-types I-VI) based on a series of multi-site clinical studies.

The purpose of this post-marketing study is to support the claims for removal of unwanted hair and for permanent hair reduction in the compact version of the device.


Clinical Trial Description

The purpose of this post-marketing study is to determine the efficacy of the mē mini hair removal device and to compare the extent of hair removal with and without maintenance treatments.

Healthy females, with dark hair in the treatment areas that desire to remove their hair will be enrolled. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". Subjects will receive 7 "basic treatments" in weekly intervals and 3 additional maintenance treatments on 1 side in 1 month intervals ("Maintenance" vs "No maintenance" side). In the second phase of the study subjects that consented to and completed the first phase will be offered the option to continue with 9 additional maintenance treatments in 1 month intervals.

Follow ups will be conducted at 1, 3, 6, 9, and 12 months after the last basic treatment.

Evaluations will include hair clearance, skin safety, tolerability of the procedure, and subject, satisfaction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02912013
Study type Interventional
Source Iluminage Ltd.
Contact
Status Terminated
Phase N/A
Start date February 1, 2017
Completion date March 1, 2018

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