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To measure the safety of hair removal device when used frequently.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hair2Go (Mē) | Experimental | Treatment with Hair2Go (Mē)device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair2Go (Mē) | Device | Treatment with Hair2Go (Mē) three times every 2-4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
The safety of the device will be confirmed if no device related serious adverse event will occur. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0, 3, 7 days (after treatment #1, #2, and #3 respectively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome M Garden, MD | Northwestern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician Laser and Dermatology Institute | Chicago | Illinois | 60611 | United States |
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The recruitment was conducted in a medical clinic. The recruitment continued from January to June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hair2Go (Mē) | Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hair2Go (Mē) | Treatment with Hair2Go (Mē)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 | 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:
The safety of the device will be confirmed if no device related serious adverse event will occur. | Intention to treat analysis - all participants that received at least 1 treatment. | Posted | Number | 95% Confidence Interval | percentage of particpants | Up to 3 months |
|
1 year
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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 (Mē) | Treatment with Hair2Go (Mē)device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerome M. Garden | Northwestern Memorial Hospital | 312-280-0891 | j-garden@northwestern.edu |
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| Hair Clearance | Hair Clearance = the percent of hair cleared from baseline to follow up | 8 weeks after last treatment |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Treatment with Hair2Go (Mē)device
|
|
| 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) | Posted | Number | number of areas | 0, 3, 7 days (after treatment #1, #2, and #3 respectively) | Treatment areas | Participants |
|
|
|
| Secondary | Hair Clearance | Hair Clearance = the percent of hair cleared from baseline to follow up | Posted | Median | Standard Deviation | %baseline hair count | 8 weeks after last treatment | Treated areas | Participants |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
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| Treatment areas |
|
| Mild pain |
|
| Moderate Pain |
|