CompletedNCT01348776Updated Apr 4, 2013Results posted

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

An interventional study of Hair2Go (Mē) in Hair Removal, sponsored by Syneron Medical. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-04.

Sponsored by Syneron Medical · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 87
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair removal device and to compare the extent of hair removal with and without maintenance treatments. Preferably, two anatomical regions to be treated will be selected including the axilla and either the legs (calves) or forearms. The size of the area treated will be approximately 5x5 cm2. Additional areas including the face can be treated according to the subject's request with the PI's discretion but are not mandatory. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". The duration of the treatment session is approximately 30-60 minutes. Each of the selected anatomical regions (both left and right sides) will be treated with either low, medium, or high Elōs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elōs energy levels only. Only the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg will not be treated and will serve as a reference for the temporal changes in hair growth that might be subject to factors, including fluctuations in hormone levels. Both sides (left and right) of the same anatomical region will receive the basic treatments. One side will receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No maintenance" side) until the end of the experiment. More specifically, the study includes up to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be conducted at 4 and 12 weeks after the last basic treatment.

Conditions studied

Hair Removal

Keywords

hair reduction
hair removal
hair clearance

In context

Lead sponsor

Syneron Medical is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

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.
Subject has a history of immunosuppressant/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
Medication/treatments
Subject had rotating type tweezer epilator treatment, or waxing within the last 3 weeks
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 within the last 6 months.
Subject is taking medication known to induce photosensitivity, including non-steroidal anti-inflammatory agents, tetracyclines, phenothiazines, thiazide diuretics, sulfonylureas, sulfonamides, Dacarbazine(DTIC), fluorouracil, vinblastine, and griseofulvin within 4 weeks of therapy.
Subject has been taking Accutane® within 6 months of therapy.
Subject has been on steroid regimen during the last three months.
Subject is on Gold therapy (for arthritis treatment).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 87 participants (actual)

Study arms

Experimental
Hair2Go (Mē)
Subjects treated with Hair2Go (Mē) Device
Device: Hair2Go (Mē)

Interventions

DeviceHair2Go (Mē)
Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
Also known as: Mē my elōs

What researchers measure

Primary outcomes

Hair Clearance 1 Month After Last Treatment
Hair clearance = the percent of hair cleared from baseline to endpoint.
Time frame: 3 months (1 month after 7 weekly treatments)

Secondary outcomes

Hair Clearance at 3-month (Final) Follow up
Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.
Time frame: 5 months (3 months after 7 weekly treatments)
Occurrence of Anticipated Effects on Skin
As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.
Time frame: Up to 19 weeks
Tolerability Level of the Procedure Following Treatments
Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable \[had to stop treatment\]) . The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.
Time frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
Subject Satisfaction
Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
Time frame: 5 months (final follow up)

Results

Posted Apr 4, 2013

Participant flow

The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.

Participant flow — Overall Study
Milestone	Hair2Go (Me)
Started	87
Completed	84
Not completed	3
Withdrew: Lost to follow-up	3

Outcome measures

PrimaryHair Clearance 1 Month After Last Treatment

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

Time frame:: 3 months (1 month after 7 weekly treatments)
Reported as:: Mean · %baseline hair count

Hair Clearance 1 Month After Last Treatment
%baseline hair count	Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)	Hair2Go (Mē) no Maintenance Side
Hair Clearance 1 Month After Last Treatment	56.83 ± 42.96	54.08 ± 41.21

SecondaryHair Clearance at 3-month (Final) Follow up

Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.

Time frame:: 5 months (3 months after 7 weekly treatments)
Reported as:: Mean · %baseline hair count

Hair Clearance at 3-month (Final) Follow up
%baseline hair count	Maintenance Side	No Maintenance Side
Hair Clearance at 3-month (Final) Follow up	58.3 ± 37.4	44.2 ± 38.4

SecondaryOccurrence of Anticipated Effects on Skin

As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.

Time frame:: Up to 19 weeks
Reported as:: Number · Number of reports

Occurrence of Anticipated Effects on Skin
Number of reports	Anticipated Skin Effects
Erythema	20
Pruritis	2
Edema	2
Inflammation	2

SecondaryTolerability Level of the Procedure Following Treatments

Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable \[had to stop treatment\]) . The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.

Time frame:: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
Reported as:: Number · % treated areas

Tolerability Level of the Procedure Following Treatments
% treated areas	Treatment #1	Treatment #3	Treatment #7	Maintenance Treatment #3
No Pain	83.13	91.52	89.09	86.99
Mild Pain	13.86	8.48	8.48	11.64
Moderate Pain	3.01	0	2.42	1.37
Severe Pain	0	0	0	0
Intolerable (had to stop treatment)	0	0	0	0

SecondarySubject Satisfaction

Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.

Time frame:: 5 months (final follow up)
Reported as:: Number · participants

Subject Satisfaction
participants	Hair2Go (Mē)
Very satisfied	31
Satisfied	33
Slightly satisfied	9
No opinion	4
Unsatisfied	8

Adverse events

Collected over 5 month - from 1st treatment to last follow up. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Hair2Go (Me)	—	0/87 (0%)	3/87 (3.4%)

Most frequent other events

Most frequent other events
Event	Hair2Go (Me)
Severe PainSkin and subcutaneous tissue disorders	2/87
BlisterSkin and subcutaneous tissue disorders	1/87

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Hair2Go (Me)
<=18 years	0
Between 18 and 65 years	87
>=65 years	0

Age Continuous
Age Continuous(years)	Hair2Go (Me)
Mean	36.4 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	Hair2Go (Me)
Female	79
Male	8

Region of Enrollment
Region of Enrollment(participants)	Hair2Go (Me)
United States	87

Study locations

4 sites

South Coast Dermatology
Tustin, California 92780, United States
Dr Jerome Garden
Chicago, Illinois 60611, United States
Zel Skin and Laser Specialist
Edina, Minnesota 55435, United States
Tennessee Clinical Research Center
Nashville, Tennessee 37215, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01348776
Lead sponsor: Syneron Medical
Responsible party: Sponsor
First posted: May 5, 2011
Start date: Mar 2011
Primary completion: Jun 2012
Completion: Jun 2012
Results posted: Apr 4, 2013
Last update: Apr 4, 2013

Study contacts

Jerome M Garden, MD

principal investigator · Northwestern Memorial Hospital

Vince Afsahi, MD

principal investigator · South Coast Dermatology Institute

Brian D Zelickson, MD

principal investigator · Abbot Northwestern Hospital Center for Cosmetic Care

Michael Gold, MD

principal investigator · Tennessee Clinical Research Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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