An interventional study of Cutometer and Photographs in Skin Abnormalities, sponsored by Venus Concept. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Venus Concept · Not applicable, Interventional, and Treatment
This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's enrollment of 48 is above the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →Venus Concept is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Cutometer · Other: Photographs
Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.
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.
Time frame: 20 weeks after the last study treatment
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.
Time frame: 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.
Time frame: 7 weeks and 20 weeks post study treatments.
| Milestone | RF and PEMF Therapy |
|---|---|
| Started | 48 |
| Completed | 38 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| ratio | RF and PEMF Therapy |
|---|---|
| Mean R2 Cutometer Reading Baseline | 0.7658 ± 0.1127 |
| Mean R2 Cutometer Reading Wk 20 | 0.7244 ± 0.1487 |
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.
| score on a scale | RF and PEMF Therapy |
|---|---|
| Mean Satisfaction week 7 post Tx | 3.11 ± 0.92 |
| Mean Satisfaction Week 20 post Tx | 2.58 ± 1.12 |
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.
| score on a scale | RF and PEMF Therapy |
|---|---|
| Mean GAIS week 7 post Tx | 1.19 ± 0.92 |
| Mean GAIS week 20 post Tx | 0.58 ± 0.74 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RF and PEMF Therapy | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Age, Categorical(Participants) | Treatment Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 38 |
| >=65 years | 10 |
| Sex/Gender, Customized(participants) | Treatment Group |
|---|---|
| Female | 48 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 45 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 43 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Treatment Group |
|---|---|
| Canada | 48 |
| Baseline cutometer reading(ratio) | Treatment Group |
|---|---|
| Mean | 0.7658 ± 0.1127 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.