Clinical Evaluation of Silk'n Glide for Face

• Sponsor: Home Skinovations Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02103608
• Collaborator: (none)
• Enrollment: 17
• Arm: 1
• Duration (Months): 15

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hirsutism	Device: Glide	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Silk'n Glide for Face
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Home Skinovations Ltd.

Investigators

• Principal Investigator: Michael H Gold, MD, Tennessee Clinical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Home Skinovations Ltd.
• ClinicalTrials.gov Identifier: NCT02103608
• Other Study ID Numbers: DO105306A
• First Posted: Apr 4, 2014
• Last Update Posted: Sep 10, 2018
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Home Skinovations Ltd.: at Home Photo depilation device, Silk'n.
• Additional relevant MeSH terms: Hirsutism

Study Results

Participant Flow

Arm/Group Title	Glide Device
Arm/Group Description	Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
Period Title: Overall Study
STARTED	17
COMPLETED	15
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Glide Device
Arm/Group Description	Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	17 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	17 100%
Hair count at baseline (hair strands/cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hair strands/cm^2]	22.7 (14.6)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Individuals who could benefit from hair reduction

Arm/Group Title	Glide Device
Arm/Group Description	Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
Measure Participants	15
4 weeks follow up	83.3 (22.5)
12 weeks follow up	78.1 (34.2)

Adverse Events

Arm/Group Title	Glide Device
Arm/Group Description	Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart.
All Cause Mortality
	Glide Device
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Glide Device
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Glide Device
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.