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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.
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 ElĹŤs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elĹŤs 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hair2Go (MÄ“) | Experimental | Subjects treated with Hair2Go (MÄ“) Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair2Go (MÄ“) | Device | Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 months (3 months after 7 weekly treatments) |
| Occurrence of Anticipated Effects on Skin |
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Inclusion 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).
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| 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 |
| Michael Gold, MD | Tennessee Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast Dermatology | Tustin | California | 92780 | United States | ||
| Dr Jerome Garden |
3 subjects were found not eligible and 1 withdrew the informed consent before beginning treatments.
The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hair2Go (Me) | Subjects treated with the Hair2Go (Me) Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hair2Go (Me) | Subjects treated with the Hair2Go (Me) Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hair Clearance 1 Month After Last Treatment | Hair clearance = the percent of hair cleared from baseline to endpoint. | Sample size was discussed with the FDA during a pre-IDE meeting. | Posted | Mean | Standard Deviation | %baseline hair count | 3 months (1 month after 7 weekly treatments) | areas of treatment | Participants |
|
5 month - from 1st treatment to last follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hair2Go (Me) | Subjects treated with the Hair2Go (Me) Device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doran Rozen, Director of Clinical Affairs | Syneron Beauty | +972-54-7800260 | Doran.Rozen@syneron.com |
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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. |
| 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. | 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. | 5 months (final follow up) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Zel Skin and Laser Specialist | Edina | Minnesota | 55435 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | All areas with photos that allowed reliable hair counting were included for this analysis. | Posted | Mean | Standard Error | %baseline hair count | 5 months (3 months after 7 weekly treatments) | Treatment Areas | Participants |
|
|
|
| Secondary | 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. | Posted | Number | Number of reports | Up to 19 weeks | total treatments | Participants |
|
|
|
| Secondary | 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. | Posted | Number | % treated areas | 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3) | Treatment areas analyzed | Participants |
|
|
|
| Secondary | Subject Satisfaction | Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale. | Two subjects did not report on satisfaction. | Posted | Number | participants | 5 months (final follow up) |
|
|
|
| 0 |
| 87 |
| 3 |
| 87 |
| Severe Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|
|
| Inflammation |
|
| Treatment areas analyzed |
|
| Mild Pain |
|
| Moderate Pain |
|
| Severe Pain |
|
| Intolerable (had to stop treatment) |
|
| No opinion |
|
| Unsatisfied |
|