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CompletedNCT02919007Updated Oct 31, 2018Results posted

Silk'n HST Device Usability and Self Selection Study

An interventional study of Silk'n HST treatment in Wrinkles, sponsored by Home Skinovations Ltd.. Completed. Open to participants aged 18 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by Home Skinovations Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 72 Years
Sex
All
01

Study summary

This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.

Read the detailed description

Study objectives:

To test the Silk'n HST Device usability, i.e., the self-selection, labeling comprehension, and safe and effective device use by potential end users, under actual use conditions. Additionally, this study was aimed to evaluate if contraindicated subjects self-exclude from use of the device.

Investigation Design:

The study is a usability study. Twenty five potential participants were enrolled in a single location (shopping mall). Participants received the Silk'n HST device in its original package with the complete user manual and performed a full treatment. Post-treatment questionnaire and labeling comprehension exam were conducted following treatment. Out of the twenty five subjects five participants contraindicated to the study inclusion criteria were self-exclude from use of the device.

Success criteria:

Using the device, all 20 tested subjects are able to complete device related tasks, including applying and operating the Silk'n device without assistance in a timeframe of up to one hour and with minimal attempts to ask for assistance.

Additionally, measurable usability criteria for specific, critical steps, such as time-to-completion, frequency of attempts to ask examiner, numerical ratings, etc., were evaluated using observer evaluation and user post-test questionnaire responses.

Sample Size:

Twenty five subjects identified as potential end users of the device including five subjects with contraindication to the device were recruited to the study. The number of subjects is appropriate considering the device and user related risks, low probable occurrence and severity of these risks, and the design of the study. Furthermore, usability studies are not seeking statistical significance.

02

Conditions studied

  • Wrinkles
03

In context

Lead sponsor

Home Skinovations Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Silk'n HST treatment

    Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual. Measure includes the ability to operate the device correctly according to the user manual.

    Device: Silk'n HST treatment

Interventions

  • DeviceSilk'n HST treatment

    Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual

06

What researchers measure

Primary outcomes

  1. Usability Assessment

    Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.

    Time frame: 1 hour

07

Results

Posted Sep 27, 2018

Participant flow

Participant flow — Overall Study
MilestoneSilk'h HST Treatment
Started25
Completed25
Not completed0

Outcome measures

PrimaryUsability Assessment

Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.

Time frame:
1 hour
Reported as:
Count of participants · Participants
Usability Assessment
ParticipantsSilk'n HST Treatment
Usability Assessment25

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Silk'h HST Treatment—0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Silk'h HST Treatment
<=18 years0
Between 18 and 65 years18
>=65 years7
Age, Continuous
Age, Continuous(years)Silk'h HST Treatment
Mean49.2 ± 15.9
Sex: Female, Male
Sex: Female, Male(Participants)Silk'h HST Treatment
Female17
Male8
Region of Enrollment
Region of Enrollment(Participants)Silk'h HST Treatment
United States25
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02919007
Lead sponsor
Home Skinovations Ltd.
Responsible party
Sponsor
First posted
Sep 29, 2016
Start date
Dec 2015
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Sep 27, 2018
Last update
Oct 31, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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