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This is a clinical study to determine the efficacy and safety of the Glide, hair removal photo-depilation device, for removing facial hairs. During the first stage, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.
Study efficacy assessment:
Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.
Study safety assessment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percentage of hair reduction | Experimental | This is an open label, prospective study to evaluate safety and efficiency of Silk'n Glide on the face. During the study, the subjects will perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glide | Device | 6 facial hair reduction treatments with the Glide device, two weeks apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. | Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated. | 4 weeks and 12 weeks post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Gold, MD | Tennessee Clinical Research Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glide Device | Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Glide Device | Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart. |
| 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 | 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. | Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated. | Individuals who could benefit from hair reduction | Posted | Mean | Standard Deviation | percentage of hair reduction | 4 weeks and 12 weeks post treatment |
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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 | Glide Device | Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Gold | Tennesse clinical research center | 615-383-2400 | drgold@goldskincare.com |
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| ID | Term |
|---|---|
| D006628 | Hirsutism |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014770 | Virilism |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hair count at baseline | Mean | Standard Deviation | hair strands/cm^2 |
|
|
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |