Clinical trial NCT02103608: Clinical Evaluation of Silk'n Glide for Face
Official title: Clinical Evaluation of Silk'n Glide for Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hirsutism
Keywords: at Home Photo depilation device, Silk'n.
Lead sponsor: Home Skinovations Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.
timeFrame: 4 weeks and 12 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tennessee Clinical Research Center
name: Michael H Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: