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:
41 studies on the registry are indexed under Hirsutism; 8 are open to participants now.
This study's enrollment of 17 is below the median of 43 across 26 interventional studies indexed under Hirsutism.
Browse Hirsutism studies →Home Skinovations Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The record gives a start of Sep 2013, a primary completion of Jul 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2018, 4 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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.