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N/A N=25 Treatment

Silk'n HST Device Usability and Self Selection Study

Wrinkles

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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