Long Term Efficiency of the Hair2Go Device

NCT01529931 | Completed

• 2 other identifiers: OHR-8-FU-1YDC83411
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (1)

• Hair clearance at final follow up

  Hair clearance will be calculated at the final follow-up treatment from the hair counts conducted by independent blinded reviewer(s) based on photographs of treatment sites.

  1 year after last basic treatment (termination)

Study Arms (1)

Maintenance

EXPERIMENTAL

This arm receives Hair2Go treatments once a month for 6 months

Device: Hair2Go

Interventions

Hair2Go DEVICE

Hair2Go treatment once a month for 6 months

Also known as: Mē my elōs

Maintenance

Eligibility Criteria

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

You may qualify if:

• Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
• Healthy males and females, between 18 and 65 years of age.
• Willing to sign informed consent.
• Willing to follow the protocol schedule.
• Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
• Willingness to avoid shaving 1 week prior to the visits.

You may not qualify if:

• Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
• Subject had electrolysis treatment within the last 6 months over the treatment area.
• Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

South Dermatology Institute

Tustin, California, 92780, United States

Location

Dr Jerome Garden

Chicago, Illinois, 60611, United States

Location

Zel Skin & Laser Specialists

Edina, Minnesota, 55424, United States

Location

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

• Lilach Gavish, PhD

  Hebrew University of Jerusalem

Study Design

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

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 9, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)