Hair Removal
Conditions
Keywords
Hair removal, Hair Clearance, Epilation
Brief summary
To measure the safety of hair removal device when used frequently.
Detailed description
The primary endpoint of this study is to measure the safety of the Hair2Go device when used frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks after the last treatment, and gathering information about the pain associated with the procedure
Interventions
DEVICEHair2Go (Mē)
Treatment with Hair2Go (Mē) three times every 2-4 days
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
* Healthy males and females, between 18 and 65 years of age. * 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 treatments
Exclusion criteria
* 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 * 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. * Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months * 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. * Participation in a study of another device or drug within 1 month prior to enrollment or during this study. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. | Up to 3 months | The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | 0, 3, 7 days (after treatment #1, #2, and #3 respectively) | Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification) |
| Hair Clearance | 8 weeks after last treatment | Hair Clearance = the percent of hair cleared from baseline to follow up |
Countries
United States
Participant flow
Recruitment details
The recruitment was conducted in a medical clinic. The recruitment continued from January to June 2011.
Participants by arm
| Arm | Count |
|---|---|
| Hair2Go (Mē) Treatment with Hair2Go (Mē)device | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Hair2Go (Mē) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Age Continuous | 32.5 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 29 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 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.
The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.
Time frame: Up to 3 months
Population: Intention to treat analysis - all participants that received at least 1 treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hair2Go (Mē) | Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. | Anticipated skin effects | 0 percentage of particpants |
| Hair2Go (Mē) | Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. | Device related serious adverse events | 0 percentage of particpants |
| Hair2Go (Mē) | Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. | Device related adverse events | 0 percentage of particpants |
Secondary
Hair Clearance
Hair Clearance = the percent of hair cleared from baseline to follow up
Time frame: 8 weeks after last treatment
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Hair2Go (Mē) | Hair Clearance | 44.19 %baseline hair count | Standard Deviation 31.09 |
Secondary
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.
Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)
Time frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hair2Go (Mē) | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 4 number of areas |
| Hair2Go (Mē) | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 82 number of areas |
| Hair2Go (Mē) | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 0 number of areas |
| Light Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 2 number of areas |
| Light Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 80 number of areas |
| Light Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 0 number of areas |
| Light Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 0 number of areas |
| Light Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 70 number of areas |
| Light Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 0 number of areas |
| Dark Skin - Treat#1 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 13 number of areas |
| Dark Skin - Treat#1 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 50 number of areas |
| Dark Skin - Treat#1 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 5 number of areas |
| Dark Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 13 number of areas |
| Dark Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 53 number of areas |
| Dark Skin - Treat#2 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 2 number of areas |
| Dark Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | No Pain | 54 number of areas |
| Dark Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Moderate Pain | 2 number of areas |
| Dark Skin - Treat#3 | Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. | Mild pain | 12 number of areas |