The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design

NCT01348776 | Completed Results DMC

• 1 other identifier: OHR-2
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design.

Conditions

Hair Removal

Keywords

hair reduction; hair removal; hair clearance

Outcome Measures

Primary Outcomes (1)

• Hair Clearance 1 Month After Last Treatment

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

  3 months (1 month after 7 weekly treatments)

Secondary Outcomes (4)

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

  5 months (3 months after 7 weekly treatments)

• Occurrence of Anticipated Effects on Skin

  Up to 19 weeks

• Tolerability Level of the Procedure Following Treatments

  1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)

• Subject Satisfaction

  5 months (final follow up)

Study Arms (1)

Hair2Go (Mē)

EXPERIMENTAL

Subjects treated with Hair2Go (Mē) Device

Device: Hair2Go (Mē)

Interventions

Hair2Go (Mē) DEVICE

Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months

Also known as: Mē my elōs

Hair2Go (Mē)

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
• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (4)

South Coast Dermatology

Tustin, California, 92780, United States

Location

Dr Jerome Garden

Chicago, Illinois, 60611, United States

Location

Zel Skin and Laser Specialist

Edina, Minnesota, 55435, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Results Point of Contact

• Title: Doran Rozen, Director of Clinical Affairs
• Organization: Syneron Beauty

Doran.Rozen@syneron.com

+972-54-7800260

Study Officials

• Jerome M Garden, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Vince Afsahi, MD

  South Coast Dermatology Institute

  PRINCIPAL INVESTIGATOR

• Brian D Zelickson, MD

  Abbot Northwestern Hospital Center for Cosmetic Care

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD

  Tennessee Clinical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: May 2, 2011
• First Posted: May 5, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 4, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-04

Locations

US (4)