N/A
N=17
Clinical Evaluation of Silk'n Glide for Face
Hirsutism
Bottom Line
View on ClinicalTrials.gov: NCT02103608 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. — 83.3; 78.1 percentage of hair reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Glide (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Home Skinovations Ltd.
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits. |
83.3; 78.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Presence of unwanted hairs on the face
- Skin Type I to IV (Fitzpatrick)
- Adults older than 21 years of age but not more than 60 years of age.
- 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).
- Informed consent agreement by the subject.
- Willingness to follow the treatment schedule and post treatment care.
Exclusion Criteria
- Malignant or pre-malignant pigmented lesions in the area to be treated.
- Scarring or infection of the area to be treated.
- Known photosensitivity.
- Pregnancy or lactating
- Subjects with Diabetes (Type I or II).
- Presence of a suntan in the area to be treated.
- Use of medication known to induce photosensitivity.
- Subject is on anticoagulative medication or throm-boembolic condition.
- Subjects with a pacemaker or internal defibrillator.
- Use of NSAIDS two weeks prior to, and two weeks following the treatment.
- Subjects that use waxing or other methods of photo-epilation 3 months prior to treatment.
- Subjects that have been exposed to strong sunlight or an artificial tanning machine during the past 4 weeks
- Subjects wearing a tattoo or permanent makeup on the area to be treated
- Subjects with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated
- Subjects with Eczema, psoriasis, lesions, open wounds or active infections, such as cold sores in the area to be treated
- Subjects with history of keloidal scar formation
- Subjects with history of herpes outbreaks in the area of treatment, unless you have consulted your physician and received preventative treatment before using GlideTM
- Subjects with epilepsy
- Subjects using incontinence device, insulin pump, other active devices [NB: Protocol excludes pace-makers and internal defibrillators.]
- Subjects with a history of skin cancer or areas of po-tential skin malignancies
- Subjects who have received radiation therapy or chemotherapy treatments within the past 3 months
Data sourced from ClinicalTrials.gov (NCT02103608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.