Cicatrix, HypertrophicNCT03366194

The Clinical Efficacy And Safety Of SkinStylus Microneedling System

A study testing SkinStylus Sterilock System in people with Cicatrix, Hypertrophic, run by Esthetic Education LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars. Read more about this study

Who is it for?: Ages 23 years and olderHealthy volunteers can take part
Conditions the study is for: Cicatrix, Hypertrophic
What is being tested?: SkinStylus Sterilock System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2017to 1 Dec 2018
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 23 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

at least 23 years old
shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Who cannot join

Pregnancy or chance of pregnancy
Currently taking Coumadin/Warfarin® or heparin
Diagnosis of any type of bleeding disorder
Any history of keloid formation
Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity
Diagnosis of mental disorders requiring inpatient treatment

Show all 12Show fewer

Presence of metal implants around the proposed treatment areas
Diagnosis of any undefined wasting disease (Cachexia for example)
Diagnosis of an active infection in the treatment area other than mild acne
Diagnosis of the presence of tumors or those who are being treated by chemotherapy or radiation therapy
Diagnosis of severe cardiovascular and cerebrovascular disease
Diagnosis of renal failure

Trial locations and contacts

1 site in 1 country.

United States1 site

Esthetic Education LLC
Scottsdale, Arizona, 85260

Other trials in United States

About this study

Official title: The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients

The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.

Read the detailed description

The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.
Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.

Conditions: Cicatrix, Hypertrophic
Being tested: SkinStylus Sterilock System
Medical subject headings: Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SkinStylus Sterilock SystemDevice
Microneedling device will be used to treat ventral hypertrophic scars.

Study groups in NCT03366194
Study group	Role	What they receive
Experimental	Experimental	Each subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization. Receives: Device: SkinStylus Sterilock System

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar.
A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.
Measured: 90 days from date of last treatment

Secondary outcomes (1)

Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
The Self-Assessed Scar Improvement Scale is a validated 6-point scale (-1 to 4) describing the patient's opinion regarding the overall improvement of the scar after treatment with "4" constituting the patient believing that the scar had a "75%-99%" improvement, "3" constituting a "50%-75%" improvement, "2" constituting a "25%-50%" improvement, "1" constituting a "1%-25%" improvement, "0" constituting "no change", and "-1" constituting an "exacerbation of the scar's appearance". A higher score means a better outcome.
Measured: 90 days from date of last treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20171 Dec 2018

First posted8 Dec 2017
Study start15 Nov 2017
Primary completion1 Nov 2018
Study completion1 Dec 2018

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 Cicatrix, HypertrophicStudies 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
Model description: Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03366194
Sponsor's protocol ID: 20172466 2017-002
Status last verified: Apr 2022
First submitted: 4 Dec 2017
Last updated: 11 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
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Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
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Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
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Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
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Recruiting
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All Cicatrix, Hypertrophic trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
ClinicalTrials.gov ID: NCT03366194
Acronym / sponsor ID: 20172466 2017-002
Conditions: Cicatrix, Hypertrophic
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Esthetic Education LLCIndustry (pharma, biotech, devices)
Study start: 15 Nov 2017 (actual)
Primary completion: 1 Nov 2018 (actual)
Study completion: 1 Dec 2018 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 11 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the trial is to provide objective evidence the SkinStylus may be used safely and effectively for the treatment of ventral torso hypertrophic scars.

Detailed description

The SkinStylus has been designated as a non-significant risk and therefore will be granted an Investigational Device Exemption (IDE). There are no meaningful changes to the SkinStylus® instructions for use and specifically no new risks will be introduced.
Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar. This is entirely voluntary and participants may decline the treatment if they wish.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Each participant shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs. At the conclusion of the trial all participants shall be provided with a cross over treatment on the non-treated portion of the scar identical to that which was provided within the trial for the purpose of "evening" the ventral torso hypertrophic scar.

Arm	Type	Receives
Experimental	Experimental	Device: SkinStylus Sterilock SystemEach subject shall have a relatively homogenous section of the total scar divided into two relatively equal sides. One side shall be treated with SkinStylus Sterilock System and the other not treated. The side that is chosen for treatment remains constant. The side that is chosen is done so randomly and prior to meeting the subject via a coin flip randomization.

Who may qualify

Ages: 23 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

at least 23 years old
shall have at least one suitable ventral torso hypertropic scar of sufficient length that it may be easily visualized in two halfs.
The scar(s) must present along a flat surface suitable for application of the SkinStylus® device and consistent medical photography.

Key exclusion criteria (12 listed)

Pregnancy or chance of pregnancy
Currently taking Coumadin/Warfarin® or heparin
Diagnosis of any type of bleeding disorder
Any history of keloid formation
Lidocaine, tetracaine, prilocaine, bupivacaine, or benzocaine hypersensitivity

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
SkinStylus Sterilock SystemMicroneedling device will be used to treat ventral hypertrophic scars.	Device	Experimental

Primary outcome

Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
Time frame: 90 days from date of last treatment
The Visual Analog Scale Scar Scoring System (VAS Scar Scale) is a validated scar assessment scale with a minimum scar improvement value of 0.0 cm on one end of a 10.0 cm long line and 10.0 cm on the other end. The 0.0 cm represents "no change" in the appearance of the scar while 10.0 cm represents "complete resolution" of the scar. A panel of 3 expert graders viewed images of the treatment area and the control area before treatment and 90 days after the last treatment. The difference between the measurements taken at baseline and measurements taken two weeks following the end of the treatment of the treatment area was calculated for each participant, for each grader. The difference of all three graders analysis for each subject was averaged. Those participants with a VAS score on the treatment side that met the MCID of an improvement of at least 1.0 cm were identified in the results as "responders". A higher score is a better outcome.

1 secondary outcome

Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
Time frame: 90 days from date of last treatment

Results and safety

Results posted to the registry on 11 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SkinStylus Sterilock System Intervention	36	34

Primary outcome: Number of Participants With Improvement Assessed Using the VAS Scar Scoring System

Time frame: 90 days from date of last treatment. Count of participants. Unit: Participants

Measure	Experimental n = 34
Value	22

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SkinStylus Sterilock System Intervention	0 of 34 (0%)	2 of 34 (5.9%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cicatrix, Hypertrophic

Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic

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.

Toni Stockton, MD principal investigator

Principal Investigator for Esthetic Education LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SkinStylus Sterilock System in people with Cicatrix, Hypertrophic, run by Esthetic Education LLC at 1 site in United States.

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 3 inclusion and 12 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 11 May 2022). 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?

Number of Participants With Improvement Assessed Using the VAS Scar Scoring System (time frame: 90 days from date of last treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03366194.

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 11 May 2022.