Clinical Evaluation of Silk'n Glide for Face

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 Overview

• Status: Completed
• Conditions: Hirsutism
• Intervention / Treatment: Device: Glide

Detailed Description

Study efficacy assessment:

Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.

Study safety assessment:

1. Reported errors and near errors using the device
2. Device malfunctions which relate to device safety
3. Device related adverse events
4. Non device related adverse events (secondary endpoint)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percentage of hair reduction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks and 12 weeks post treatment

Collaborators and Investigators

• Sponsor: Home Skinovations Ltd.
• Investigators: Principal Investigator: Michael H Gold, MD, Tennessee Clinical Research Center

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 23, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 2, 2018
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: at Home Photo depilation device, Silk'n.
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Virilism; Hirsutism
• Other Study ID Numbers: DO105306A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No