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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Home use hair removal device
David Friedman, Skin & Laser Center
Jerusalem, Israel
Hair Clearance at 1 Month Follow up
Hair clearance = the percent of hair cleared from baseline to endpoint.
Time frame: 3 months after beginning of the study (1 month after completion of 7 weekly treatments that last 2 months)
Hair Clearance at 3-month (Final) Follow up
Hair clearance = the percent of hair cleared from baseline to endpoint.
Time frame: 5 months after beginning of the study (3 months after completion of 7 weekly treatments that last 2 months)
Occurrence of Anticipated Effects on Skin
As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.
Time frame: 1 year and 2 months (throughout the study)
Tolerability Level of the Procedure Following Treatments
Tolerability was rated by the subjects using a 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable \[had to stop treatment\]).
Time frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5, 8, 11, 14 months (maintenance monthly treatment#3, 6, 9, 12)
Subject Satisfaction
Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
Time frame: 5, 8, 11, and 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.