N/A
N=25
Silk'n HST Device Usability and Self Selection Study
Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT02919007 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Usability Assessment — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Silk'n HST treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Home Skinovations Ltd.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Assessment |
25 | — |
Summary
This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.
Eligibility Criteria
Inclusion Criteria
- Subject is male or female equal to or greater than 18 years of age.
- Subject is a potential candidate for purchasing the Silk'n HST device.
- Subject has facility with both hands.
- Subject is capable of understanding and is willing to sign informed consent.
Exclusion Criteria
- Subject with dark brown or black spots, such as large freckles, birth marks, moles or warts on the area to be treated.
- Subject with eczema, psoriasis, lesions, open wounds or active infections, such as cold sore in the area to be treated.
- Subject with a history of kelodial scar formation, a known sensitivity to light (photosensitivity) or is taking medication that makes the skin more sensitive to light, including non-steroidal anti-inflammatory agents, (e.g., aspirins, ibuprofens, acetaminophen), tetracyclines, phenothiazines, thiazide, diuretics, sulfonyluraes, sulfonamides, DTIC, fluorouracil, vinblastine, griseofulvin, Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, Accutane® and/or topical retinoids.
- Subject with abnormal skin conditions caused by diabetes, for example, or other systemic or metabolic diseases.
- Subject currently or has recently been treated with Alpha-Hydroxi Acids (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.
- Subject has been treated with Accutane® (isotretinoin) within the past 6 months.
- Subject has been on a steroid regimen within the past 3 months.
- Subject has a history of herpes outbreaks in the area of treatment.
- Subject suffers from epilepsy.
- Subject with an active implant, such as a pacemaker, incontinence device, insulin pump, etc.
- Subject with a disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc.
- Subject with a history of skin cancer or areas of potential skin malignancies.
- Subject received radiation therapy or chemotherapy treatments within the past 3 months.
- Subject is pregnant or nursing (lactating).
Data sourced from ClinicalTrials.gov (NCT02919007). 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.