Trials / Terminated
TerminatedNCT02912013
The Efficacy of the Me Mini Device for Hair Removal
The Efficacy of the Me Mini Device for Hair Removal: A Prospective, Open Label Study With Before-After Design
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Iluminage Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Me Mini | Home use hair removal device |
Timeline
- Start date
- 2017-02-01
- Primary completion
- 2017-11-03
- Completion
- 2018-03-01
- First posted
- 2016-09-23
- Last updated
- 2018-03-09
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT02912013. Inclusion in this directory is not an endorsement.