WrinklesNCT02919007
Silk'n HST Device Usability and Self Selection Study
A study testing Silk'n HST treatment in people with Wrinkles, run by Home Skinovations Ltd..
Trial summary
This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- Silk'n HST treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
About this study
Official title: Clinical Evaluation of Silk'n HST Self-selection, Labeling Comprehension, and Device Use
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.
- Conditions
- Wrinkles
- Being tested
- Silk'n HST treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk'n HST treatmentDevice
Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
| Study group | Role | What they receive |
|---|---|---|
| Silk'n HST treatment | Experimental | 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. Receives: Device: Silk'n HST treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Home Skinovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919007
- Sponsor's protocol ID
- DO111411
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2016
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Silk'n HST Self-selection, Labeling Comprehension, and Device Use
- ClinicalTrials.gov ID
- NCT02919007
- Acronym / sponsor ID
- DO111411
- Conditions
- Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Home Skinovations Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 27 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Usability study, conducted for the purpose of testing Silk'n HST Device usability.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silk'n HST treatment | Experimental | Device: Silk'n HST treatmentIntervention 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. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silk'n HST treatmentIntervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual | Device | Silk'n HST treatment |
Primary outcome
Usability Assessment
Time frame: 1 hour
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Silk'n HST treatment in people with Wrinkles, run by Home Skinovations Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Assessment (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.