Clinical Evaluation of Silk'n Glide for Face
Primary Purpose
Hirsutism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glide
Sponsored by
About this trial
This is an interventional treatment trial for Hirsutism focused on measuring at Home Photo depilation device, Silk'n.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percentage of hair reduction
Arm Description
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 .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02103608
First Posted
March 23, 2014
Last Updated
September 2, 2018
Sponsor
Home Skinovations Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02103608
Brief Title
Clinical Evaluation of Silk'n Glide for Face
Official Title
Clinical Evaluation of Silk'n Glide for Face
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Home Skinovations Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirsutism
Keywords
at Home Photo depilation device, Silk'n.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percentage of hair reduction
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Device
Intervention Name(s)
Glide
Intervention Description
6 facial hair reduction treatments with the Glide device, two weeks apart.
Primary Outcome Measure Information:
Title
1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Gold, MD
Organizational Affiliation
Tennessee Clinical Research Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Evaluation of Silk'n Glide for Face
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