Back to results

Clinical Evaluation of Silk'n Glide for Face

Primary Purpose

Hirsutism

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Glide

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:

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

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

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

Learn more about this trial

Clinical Evaluation of Silk'n Glide for Face

We'll reach out to this number within 24 hrs