An interventional study of Glide in Hirsutism, sponsored by Home Skinovations Ltd.. Completed. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Treatment
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:
Exclusion Criteria:
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 .
Device: Glide
6 facial hair reduction treatments with the Glide device, two weeks apart.
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.
Time frame: 4 weeks and 12 weeks post treatment
| Milestone | Glide Device |
|---|---|
| Started | 17 |
| Completed | 15 |
| Not completed | 2 |
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.
| percentage of hair reduction | Glide Device |
|---|---|
| 4 weeks follow up | 83.3 ± 22.5 |
| 12 weeks follow up | 78.1 ± 34.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glide Device | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Glide Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Glide Device |
|---|---|
| Female | 17 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Glide Device |
|---|
| Region of Enrollment(Participants) | Glide Device |
|---|---|
| United States | 17 |
| Hair count at baseline(hair strands/cm^2) | Glide Device |
|---|---|
| Mean | 22.7 ± 14.6 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Home Skinovations Ltd.