Hair Removal Clinical Trial
Official title:
The Efficacy of the Me Mini Device for Hair Removal: A Prospective, Open Label Study With Before-After Design
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.
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.
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