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Clinical Evaluation of Silk'n Glide for Face

Primary Purpose

Hirsutism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glide
Sponsored by
Home Skinovations Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hirsutism focused on measuring at Home Photo depilation device, Silk'n.

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Presence of unwanted hairs on the face
  2. Skin Type I to IV (Fitzpatrick)
  3. Adults older than 21 years of age but not more than 60 years of age.
  4. 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).
  5. Informed consent agreement by the subject.
  6. Willingness to follow the treatment schedule and post treatment care.

Exclusion Criteria:

  1. Malignant or pre-malignant pigmented lesions in the area to be treated.
  2. Scarring or infection of the area to be treated.
  3. Known photosensitivity.
  4. Pregnancy or lactating
  5. Subjects with Diabetes (Type I or II).
  6. Presence of a suntan in the area to be treated.
  7. Use of medication known to induce photosensitivity.
  8. Subject is on anticoagulative medication or throm-boembolic condition.
  9. Subjects with a pacemaker or internal defibrillator.
  10. Use of NSAIDS two weeks prior to, and two weeks following the treatment.
  11. Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
  12. Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
  13. Subjects wearing a tattoo or permanent makeup on the area to be treated
  14. Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
  15. Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
  16. Subjects with history of keloidal scar formation
  17. Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
  18. Subjects with epilepsy
  19. Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
  20. Subjects with a history of skin cancer or areas of po-tential skin malignancies
  21. 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

    First Posted
    March 23, 2014
    Last Updated
    September 2, 2018
    Sponsor
    Home Skinovations Ltd.
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    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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