CompletedNCT03776461Updated Aug 15, 2023Results posted

Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

An interventional study of Venus Viva in Rhytides and Wrinkle, sponsored by Venus Concept. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by Venus Concept · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Non-randomized
Ages: 22 Years and older
Sex: All

Study summary

Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.

Read the detailed description

The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment

Conditions studied

Rhytides
Wrinkle

Keywords

fractional radiofrequency
fractional RF
facial wrinkles
wrinkles

In context

Lead sponsor

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.

Browse Venus Concept studies →

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

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.
Able to read, understand and voluntarily provide written .
Able and willing to comply with the treatment/follow-up schedule and requirements.
Women of child-bearing age are required to be using a reliable method of at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion criteria

Exclusion Criteria:

Implantable defibrillators, cardiac pacemakers, and other metal implants
Subjects with any implantable metal device in the treatment area
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
Current or history of any kind of cancer, or pre-malignant moles.
Severe concurrent conditions, such as cardiac disorders.
Pregnancy or intending to become pregnant during the study and nursing.
Impaired immune system due to diseases, such as AIDS and , or use of immunosuppressive medications.
History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment , or according to Investigator's discretion .
Poorly controlled endocrine disorders, such as diabetes.
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
Any surgical procedure in the treatment area within the last six months or before complete healing.
Treating over tattoo or permanent makeup.
Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Terms in these criteria, in plain language(4)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: Single (Outcomes assessor)
Enrollment: 25 participants (actual)

Study arms

Experimental
80-pin applicator
3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks.
Device: Venus Viva
Active comparator
160 pin applicator
3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks.
Device: Venus Viva

Interventions

DeviceVenus Viva
The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.

What researchers measure

Primary outcomes

Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Time frame: 12 Weeks Post Last Treatment (Around Week 20)
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
Time frame: 6 Weeks Post Last Treatment (Around Week 14)

Secondary outcomes

Subject Scale - Visual Analog Scale for Pain
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.
Time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.
Time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits

Results

Posted Aug 4, 2023

Participant flow

Participant flow — Overall Study
Milestone	80-pin Applicator
Started	25
Completed	18
Not completed	7

Outcome measures

PrimarySubject Satisfaction

Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.

Time frame:: 12 Weeks Post Last Treatment (Around Week 20)
Reported as:: Mean · score on a scale

Subject Satisfaction
score on a scale	All Subjects
Subject Satisfaction	2.8 ± 0.8

PrimarySubject Satisfaction

Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.

Time frame:: 6 Weeks Post Last Treatment (Around Week 14)
Reported as:: Mean · units on a scale

Subject Satisfaction
units on a scale	All Subjects
Subject Satisfaction	2.6 ± 0.8

SecondarySubject Scale - Visual Analog Scale for Pain

Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.

Time frame:: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
Reported as:: Mean · units on a scale

Subject Scale - Visual Analog Scale for Pain
units on a scale	All Subjects
Subject Scale - Visual Analog Scale for Pain	3.8 ± 2.4

SecondarySubject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.

Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.

Time frame:: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
Reported as:: Mean · score on a scale

Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
score on a scale	All Subjects
Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.	3.1 ± 0.8

Adverse events

Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Participants	5/25 (20%)	0/25 (0%)	2/25 (8%)

Most frequent other events

Most frequent other events
Event	All Participants
Cold SoreInfections and infestations	2/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)	All Participants
Mean	62.4 ± 7.7

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	24
Male	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Participants
Hispanic or Latino	0
Not Hispanic or Latino	25
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Participants
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	25
More than one race	0
Unknown or Not Reported	0

Fitzpatrick Skin Type
Fitzpatrick Skin Type(participants)	All Participants
I	0
II	14
III	10
IV	0
V	0
VI	0
Unknown	1

Study locations

1 site

Scripps Clinic Carmel Valley
San Diego, California 92130, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Oct 5, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Jun 2021, 27 months.

Results were first posted in Aug 2023, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 12, 2018
First posted: Dec 14, 2018
StartActual: Mar 8, 2019
Primary completionActual: Jun 18, 2021
CompletionActual: Jun 18, 2021
Results first posted: Aug 4, 2023
Last update: Aug 15, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03776461
Lead sponsor: Venus Concept
Responsible party: Sponsor
First posted: Dec 14, 2018
Start date: Mar 8, 2019
Primary completion: Jun 18, 2021
Completion: Jun 18, 2021
Results posted: Aug 4, 2023
Last update: Aug 15, 2023

Study contacts

Matthew Gronski

study director · Venus Concept

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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