Long Term Efficiency of the Hair2Go Device | NCT01529931

Studies
Long Term Efficiency of the Hair2Go Device

NCT01529931

Sponsor

Syneron Medical

Status

Completed

Last Update Posted

Jan 18, 2019Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Hair Removal

Interventions

Hair2Go

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DC83411	Other Identifier	Syneron Beauty

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Feb 6, 2012

First Submission Date that Met QC Criteria

Feb 6, 2012

First Posted Date

Feb 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2019

Last Update Posted Date

Jan 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.

This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maintenance	Experimental	This arm receives Hair2Go treatments once a month for 6 months	Device: Hair2Go

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hair2Go	Device	Hair2Go treatment once a month for 6 months	Maintenance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Dermatology Institute		Tustin	California	92780	United States
Dr Jerome Garden

IPD Sharing Statement Module

Plan to Share IPD

Description

Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided