Clinical trial NCT01529931: Long Term Efficiency of the Hair2Go Device
Official title: Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
2. Subject had electrolysis treatment within the last 6 months over the treatment area.
3. 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).

Primary outcomes:
measure: Hair clearance at final follow up
timeFrame: 1 year after last basic treatment (termination)
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: South Dermatology Institute
state: California
city: Chicago
country: United States
facility: Dr Jerome Garden
state: Illinois
city: Edina
country: United States
facility: Zel Skin & Laser Specialists
state: Minnesota
Study officials:
affiliation: Northwestern Memorial Hospital
name: Jerome M Garden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Coast Dermatology Institute
name: Vince Afsahi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbot Northwestern Hospital Center for Cosmetic Care
name: Brian D Zelickson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University of Jerusalem
name: Lilach Gavish, PhD
References: