Hirsutism
Conditions
Keywords
at Home Photo depilation device, Silk'n.
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)
Interventions
DEVICEGlide
6 facial hair reduction treatments with the Glide device, two weeks apart.
Sponsors
Home Skinovations Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glide Device Percentage of hair reduction by the Glide device, the subjects will perform up to 6 face treatments, two weeks apart. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Glide Device | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 17 Participants | — |
| Hair count at baseline | 22.7 hair strands/cm^2 STANDARD_DEVIATION 14.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 17 Participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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.
Time frame: 4 weeks and 12 weeks post treatment
Population: Individuals who could benefit from hair reduction
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glide Device | 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. | 4 weeks follow up | 83.3 percentage of hair reduction | Standard Deviation 22.5 |
| Glide Device | 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. | 12 weeks follow up | 78.1 percentage of hair reduction | Standard Deviation 34.2 |