HirsutismNCT02103608
Clinical Evaluation of Silk'n Glide for Face
A study testing Glide in people with Hirsutism, run by Home Skinovations Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hirsutism
- What is being tested?
- Glide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of unwanted hairs on the face
- Skin Type I to IV (Fitzpatrick)
- Adults older than 21 years of age but not more than 60 years of age.
- Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
- Informed consent agreement by the subject.
- Willingness to follow the treatment schedule and post treatment care.
Who cannot join
- Malignant or pre-malignant pigmented lesions in the area to be treated.
- Scarring or infection of the area to be treated.
- Known photosensitivity.
- Pregnancy or lactating
- Subjects with Diabetes (Type I or II).
- Presence of a suntan in the area to be treated.
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- Use of medication known to induce photosensitivity.
- Subject is on anticoagulative medication or throm-boembolic condition.
- Subjects with a pacemaker or internal defibrillator.
- Use of NSAIDS two weeks prior to, and two weeks following the treatment.
- Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
- Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
- Subjects wearing a tattoo or permanent makeup on the area to be treated
- Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
- Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
- Subjects with history of keloidal scar formation
- Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
- Subjects with epilepsy
- Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
- Subjects with a history of skin cancer or areas of po-tential skin malignancies
- Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
About this study
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.
Read the detailed description
Study efficacy assessment:
Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.
Study safety assessment:
- Reported errors and near errors using the device
- Device malfunctions which relate to device safety
- Device related adverse events
- Non device related adverse events (secondary endpoint)
- Conditions
- Hirsutism
- Being tested
- Glide
- Keywords
- at Home Photo depilation device, Silk'n.
- Medical subject headings
- Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideDevice
6 facial hair reduction treatments with the Glide device, two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Glide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks and 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HirsutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Skinovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Gold, MD, Principal investigator, Tennessee Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103608
- Sponsor's protocol ID
- DO105306A
- Status last verified
- Sep 2016
- First submitted
- 23 Mar 2014
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Silk'n Glide for Face
- ClinicalTrials.gov ID
- NCT02103608
- Acronym / sponsor ID
- DO105306A
- Conditions
- Hirsutism
- Keywords
- at Home Photo depilation device, Silk'n.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Home Skinovations Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study efficacy assessment:
Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.
Study safety assessment:
- Reported errors and near errors using the device
- Device malfunctions which relate to device safety
- Device related adverse events
- Non device related adverse events (secondary endpoint)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percentage of hair reduction | Experimental | Device: GlideThis 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 . |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Presence of unwanted hairs on the face
- Skin Type I to IV (Fitzpatrick)
- Adults older than 21 years of age but not more than 60 years of age.
- Must be either post-menopausal or surgically steri-lized, or using a medically acceptable form of birth control (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or absti-nence).
- Informed consent agreement by the subject.
Key exclusion criteria (21 listed)
- Malignant or pre-malignant pigmented lesions in the area to be treated.
- Scarring or infection of the area to be treated.
- Known photosensitivity.
- Pregnancy or lactating
- Subjects with Diabetes (Type I or II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glide6 facial hair reduction treatments with the Glide device, two weeks apart. | Device | Percentage of hair reduction |
Primary outcome
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
Time frame: 4 weeks and 12 weeks post treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Gold, MD principal investigator
Tennessee Clinical Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Glide in people with Hirsutism, run by Home Skinovations Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. (time frame: 4 weeks and 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.