The Efficacy of the Me Mini Device for Hair Removal

NCT02912013 | Terminated DMC

• 1 other identifier: 303-17
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (1)

• Hair Clearance at 1 Month Follow up

  Hair clearance = the percent of hair cleared from baseline to endpoint.

  3 months after beginning of the study (1 month after completion of 7 weekly treatments that last 2 months)

Secondary Outcomes (4)

• Hair Clearance at 3-month (Final) Follow up

  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

  1 year and 2 months (throughout the study)

• Tolerability Level of the Procedure Following Treatments

  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

  5, 8, 11, and 14 months

Study Arms (1)

Me mini

EXPERIMENTAL

Subjects treated with Me mini device

Device: Me Mini

Interventions

Me Mini DEVICE

Home use hair removal device

Me mini

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females, between 18 and 65 years of age.
• Subject has Black or dark brown terminal hairs in the areas to be treated.
• Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
• Willing to sign informed consent.
• Willing to follow the treatment schedule and post treatment follow-up.
• Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications and willing to sign the photo-release form.
• Willingness to avoid excessive sun exposure two weeks prior to treatments

You may not qualify if:

• Skin and Hair
• Subjects with white, red, light brown and/ or blonde hairs in the areas to be treated.
• A history of keloidal scarring (hypertrophic scars or keloids).
• Active dermatologic lesion or infection in the treatment site.
• Subject has permanent tattoos or makeup in the treatment area.
• Recently tanned in the area to be treated and/or unable or unlikely to refrain from tanning during the study.
• Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
• Subject has a history of herpes outbreak in the area of treatment, unless receiving preventative treatment from physician Other Medical Conditions
• Pregnant, planning to become pregnant, hormone fluctuations and/or breast feeding during the experiment.
• Subjects with Diabetes (Type I or II) or other systemic or metabolic condition
• Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc.
• Subject suffers from epilepsy.
• Subject has active cancer, or has a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions.
• Subject received radiation therapy or chemotherapy treatments with the past 3 months.
• Subject has known anticoagulative or thromboembolic condition or is on any form of anticoagulation treatment.

Sponsors & Collaborators

• Iluminage Ltd.: lead

Study Sites (1)

David Friedman, Skin & Laser Center

Jerusalem, Israel

Location

Study Officials

• David J Friedman, MD

  Friedman Laser & Skin Center

  PRINCIPAL INVESTIGATOR

• Lilach Gavish, PhD

  HUJI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: September 23, 2016
• Study Start: February 1, 2017
• Primary Completion: November 3, 2017
• Study Completion: March 1, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)