Hair Removal
Conditions
Keywords
hair reduction, hair removal, hair clearance
Brief 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.
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.
Interventions
DEVICEHair2Go (Mē)
Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females, between 18 and 65 years of age. 2. Subject has Black or dark brown terminal hairs in the areas to be treated. 3. 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. 4. Willing to sign informed consent. 5. Willing to follow the treatment schedule and post treatment follow-up. 6. Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications 7. Willingness to avoid excessive sun exposure two weeks prior to treatments
Exclusion criteria
Skin and Hair 1. Subjects with white, red, light brown and/ or blonde hairs in the areas to be treated. 2. A history of keloidal scarring (hypertrophic scars or keloids). 3. Active dermatologic lesion or infection in the treatment site. 4. Subject has permanent tattoos or makeup in the treatment area. 5. Recently tanned in the area to be treated and/or unable or unlikely to refrain from tanning during the study. 6. Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc 7. Subject has a history of herpes outbreak in the area of treatment, unless receiving preventative treatment from physician Other Medical Conditions 8. Pregnant, planning to become pregnant, hormone fluctuations and/or breast feeding during the experiment. 9. Subjects with Diabetes (Type I or II) or other systemic or metabolic condition 10. Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc. 11. Subject suffers from epilepsy. 12. 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. 13. Subject received radiation therapy or chemotherapy treatments with the past 3 months. 14. Subject has known anticoagulative or thromboembolic condition or is on any form of anticoagulation treatment. 15. Subject has a history of immunosuppressant/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. 16. Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated. Medication/treatments 17. Subject had rotating type tweezer epilator treatment, or waxing within the last 3 weeks 18. Subject had electrolysis treatment within the last 6 months over the treatment area. 19. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site within the last 6 months. 20. 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. 21. Subject has been taking Accutane® within 6 months of therapy. 22. Subject has been on steroid regimen during the last three months. 23. Subject is on Gold therapy (for arthritis treatment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Clearance 1 Month After Last Treatment | 3 months (1 month after 7 weekly treatments) | Hair clearance = the percent of hair cleared from baseline to endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair Clearance at 3-month (Final) Follow up | 5 months (3 months after 7 weekly treatments) | Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments. |
| Occurrence of Anticipated Effects on Skin | Up to 19 weeks | 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. |
| Tolerability Level of the Procedure Following Treatments | 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3) | 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. |
| Subject Satisfaction | 5 months (final follow up) | Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale. |
Countries
United States
Participant flow
Recruitment details
The recruitment was conducted in a medical clinic. The recruitment continued from April to October 2011.
Pre-assignment details
3 subjects were found not eligible and 1 withdrew the informed consent before beginning treatments.
Participants by arm
| Arm | Count |
|---|---|
| Hair2Go (Me) Subjects treated with the Hair2Go (Me) Device | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Hair2Go (Me) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age Continuous | 36.4 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 87 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 87 |
| serious Total, serious adverse events | 0 / 87 |
Outcome results
Primary
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)
Population: Sample size was discussed with the FDA during a pre-IDE meeting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Hair Clearance 1 Month After Last Treatment | 56.83 %baseline hair count | Standard Deviation 42.96 |
| Hair2Go (Mē) no Maintenance Side | Hair Clearance 1 Month After Last Treatment | 54.08 %baseline hair count | Standard Deviation 41.21 |
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.
Time frame: 5 months (3 months after 7 weekly treatments)
Population: All areas with photos that allowed reliable hair counting were included for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Hair Clearance at 3-month (Final) Follow up | 58.3 %baseline hair count | Standard Error 37.4 |
| Hair2Go (Mē) no Maintenance Side | Hair Clearance at 3-month (Final) Follow up | 44.2 %baseline hair count | Standard Error 38.4 |
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.
Time frame: Up to 19 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Occurrence of Anticipated Effects on Skin | Erythema | 20 Number of reports |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Occurrence of Anticipated Effects on Skin | Pruritis | 2 Number of reports |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Occurrence of Anticipated Effects on Skin | Edema | 2 Number of reports |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Occurrence of Anticipated Effects on Skin | Inflammation | 2 Number of reports |
Secondary
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)
Population: Two subjects did not report on satisfaction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Subject Satisfaction | Very satisfied | 31 participants |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Subject Satisfaction | Satisfied | 33 participants |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Subject Satisfaction | Slightly satisfied | 9 participants |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Subject Satisfaction | No opinion | 4 participants |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Subject Satisfaction | Unsatisfied | 8 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.
Time frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Tolerability Level of the Procedure Following Treatments | Mild Pain | 13.86 % treated areas |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Tolerability Level of the Procedure Following Treatments | Intolerable (had to stop treatment) | 0 % treated areas |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Tolerability Level of the Procedure Following Treatments | Severe Pain | 0 % treated areas |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Tolerability Level of the Procedure Following Treatments | No Pain | 83.13 % treated areas |
| Hair2Go (Mē) Maintenance Side (Before Maintenance Tx) | Tolerability Level of the Procedure Following Treatments | Moderate Pain | 3.01 % treated areas |
| Hair2Go (Mē) no Maintenance Side | Tolerability Level of the Procedure Following Treatments | No Pain | 91.52 % treated areas |
| Hair2Go (Mē) no Maintenance Side | Tolerability Level of the Procedure Following Treatments | Moderate Pain | 0 % treated areas |
| Hair2Go (Mē) no Maintenance Side | Tolerability Level of the Procedure Following Treatments | Severe Pain | 0 % treated areas |
| Hair2Go (Mē) no Maintenance Side | Tolerability Level of the Procedure Following Treatments | Intolerable (had to stop treatment) | 0 % treated areas |
| Hair2Go (Mē) no Maintenance Side | Tolerability Level of the Procedure Following Treatments | Mild Pain | 8.48 % treated areas |
| Treatment #7 | Tolerability Level of the Procedure Following Treatments | Intolerable (had to stop treatment) | 0 % treated areas |
| Treatment #7 | Tolerability Level of the Procedure Following Treatments | Mild Pain | 8.48 % treated areas |
| Treatment #7 | Tolerability Level of the Procedure Following Treatments | No Pain | 89.09 % treated areas |
| Treatment #7 | Tolerability Level of the Procedure Following Treatments | Moderate Pain | 2.42 % treated areas |
| Treatment #7 | Tolerability Level of the Procedure Following Treatments | Severe Pain | 0 % treated areas |
| Maintenance Treatment #3 | Tolerability Level of the Procedure Following Treatments | Moderate Pain | 1.37 % treated areas |
| Maintenance Treatment #3 | Tolerability Level of the Procedure Following Treatments | Intolerable (had to stop treatment) | 0 % treated areas |
| Maintenance Treatment #3 | Tolerability Level of the Procedure Following Treatments | Severe Pain | 0 % treated areas |
| Maintenance Treatment #3 | Tolerability Level of the Procedure Following Treatments | Mild Pain | 11.64 % treated areas |
| Maintenance Treatment #3 | Tolerability Level of the Procedure Following Treatments | No Pain | 86.99 % treated areas |