Clinical Evaluation of Silk'n Glide for Face

NCT ID: NCT02103608

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-12-31

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:

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)

Conditions

Hirsutism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Glide

Intervention Type: DEVICE

6 facial hair reduction treatments with the Glide device, two weeks apart.

Interventions

Glide

6 facial hair reduction treatments with the Glide device, two weeks apart.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Home Skinovations Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Clinical Research Center

Other Identifiers

DO105306A

Identifier Type: -

Identifier Source: org_study_id