Skin AbnormalitiesNCT03002194

Change in Skin Elasticity With RF and PEMF

A study testing Cutometer and Photographs in people with Skin Abnormalities, run by Venus Concept at 1 site in Canada.

Completed

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

Trial summary

This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Skin Abnormalities
What is being tested?: Cutometer and Photographs
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteCanada
Study dates: Nov 2016to 29 Sep 2017
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen

Who cannot join

Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
Prior use of retinoids in treated area within 2 weeks of initial treatment
Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
Patient on systemic corticosteroid therapy 6 months prior to start of study
Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.
Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment

Show all 15Show fewer

Any other surgery in treated area within 12 months of initial treatment
History of keloid formation or poor wound healing in a previously injured skin area
Epidermal or dermal disorders
Open laceration or abrasion of any sort on the area to be treated.
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Having any form of active cancer at the time of enrollment
Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process
Participation in a study of another device or drug within 1 month prior to study enrollment
Tattoos in the treatment area.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Art of Facial Surgery
North York, Ontario, M2N 6H7

Other trials in Canada

About this study

Official title: Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment

This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.

Read the detailed description

This study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (RF) and pulsed electromagnetic field (PEMF) treatment. Forty-five adult females will undergo weekly treatments over a period of 8 weeks. Skin elasticity will be measured by a Cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment. Photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment. Patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.

Conditions: Skin Abnormalities
Being tested: Cutometer, Photographs
Keywords: rhytides, wrinkle
Medical subject headings: Skin Abnormalities

What participants receive

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

CutometerDevice
Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
PhotographsOther
Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Study groups in NCT03002194
Study group	Role	What they receive
RF and PEMF therapy	Experimental	Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs. Receives: Device: Cutometer; Other: Photographs

What is being measured

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

Change in Facial Skin Elasticity
A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.
Measured: 20 weeks after the last study treatment

Secondary outcomes (2)

Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
Subject will assign a score that best represents the level of satisfaction they have in their appearance as a result of the study treatment. The scale reports five categories - 4 - very satisfied; 3 - satisfied; 2 - having no opinion; 1 - unsatisfied and 0 - very unsatisfied. The higher the score, the more satisfaction with the treatment that a subject reports.
Measured: 7 weeks and 20 weeks post study treatments
General Aesthetic Improvement Scale (GAIS)
Subject to assess their general improvement in appearance at 7 and 20 weeks post-intervention using a 7 category scale: 3 - very much improved; 2 - much improved; 1 - improved; 0 - no change; -1 - worse; -2 - much worse and -3 very much worse. The higher the positive score, the more the subject feels their appearance has changed for the better.
Measured: 7 weeks and 20 weeks post study treatments.

Timeline

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

Nov 201629 Sep 2017

First posted23 Dec 2016 (estimated)
Study startNov 2016
Primary completion29 Sep 2017
Study completion29 Sep 2017

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 Skin AbnormalitiesStudies 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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03002194
Sponsor's protocol ID: CS0316
Status last verified: Apr 2020
First submitted: 24 Nov 2016
Last updated: 27 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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All Skin Abnormalities trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment
ClinicalTrials.gov ID: NCT03002194
Acronym / sponsor ID: CS0316
Conditions: Skin Abnormalities
Keywords: rhytides, wrinkle
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Venus ConceptIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: 29 Sep 2017 (actual)
Study completion: 29 Sep 2017 (actual)
First posted: 23 Dec 2016 (estimated)
Results: Posted 27 Apr 2020

Clinical summary

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

This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
RF and PEMF therapy	Experimental	Device: Cutometer, Other: PhotographsEach subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV
Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen

Key exclusion criteria (15 listed)

Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator
Prior use of retinoids in treated area within 2 weeks of initial treatment
Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment
Patient on systemic corticosteroid therapy 6 months prior to start of study
Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants.

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
CutometerSkin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.	Device	RF and PEMF therapy
PhotographsPhotographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.	Other	RF and PEMF therapy

Primary outcome

Change in Facial Skin Elasticity
Time frame: 20 weeks after the last study treatment
A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.

2 secondary outcomes

Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale
Time frame: 7 weeks and 20 weeks post study treatments
General Aesthetic Improvement Scale (GAIS)
Time frame: 7 weeks and 20 weeks post study treatments.

Results and safety

Results posted to the registry on 27 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RF and PEMF Therapy	48	38

Primary outcome: Change in Facial Skin Elasticity

Time frame: 20 weeks after the last study treatment. Mean (Standard Deviation). Unit: ratio

Measure	RF and PEMF Therapy n = 38
Mean R2 Cutometer Reading Baseline	0.7658 (0.1127)
Mean R2 Cutometer Reading Wk 20	0.7244 (0.1487)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 9 months and 18 days. All reportable events with start dates occurring any time after informed consent is obtained will be followed until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RF and PEMF Therapy	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Skin Abnormalities

RecruitingObservational study
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RecruitingObservational study
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RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
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Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
Enrolling by invitationObservational study
Advanced Ultrasound Signal Processing of Suspicious Breast Images
Breast Cancer, Breast Cyst

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.

Yoni Iger, PhD study director

Venus Concept Ltd.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cutometer and Photographs in people with Skin Abnormalities, run by Venus Concept at 1 site in Canada.

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 2 inclusion and 15 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 27 Apr 2020. 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 Canada. 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 27 Apr 2020). 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?

Change in Facial Skin Elasticity (time frame: 20 weeks after the last study 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 NCT03002194.

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 27 Apr 2020.