Stretch MarkNCT05097573
Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
A study testing Venus Viva in people with Stretch Mark, run by Venus Concept at 1 site in Switzerland.
Trial summary
This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stretch Mark
- What is being tested?
- Venus Viva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 May 2019to 4 Oct 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, male or female subjects, 18-60 years of age who are seeking treatment for their stretch marks
- Fitzpatrick skin type I-IV
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
Who cannot join
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Subjects with any implantable metal device in the treatment area
- Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
- Current or history of any kind of cancer, or dysplastic nevi in the treated area.
- Severe concurrent conditions, such as cardiac disorders.
- Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
Show all 14Show fewer
- History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- 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.
- Use of isotretinoin (Accutane®) or other systemic retinoids limited up to 10mg/day or as per investigators discretion.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
- Conditions
- Stretch Mark
- Being tested
- Venus Viva
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus VivaDevice
The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, stretch marks, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Venus Viva | Experimental | The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart. Receives: Device: Venus Viva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment
Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.
Measured: 16 Weeks Post-Final Treatment (Week 28)
Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS)
Evaluate the efficacy of overall stretch mark improvement assessed live by the Investigator and a subject assessment of stretch mark including the Global Aesthetic Improvement Scale (GAIS).The Global Aesthetic Improvement Scale is a seven-grade subjective test. The PI evaluated before and after photographs and graded them for change.
Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).
Measured: 16 Weeks Post-Final Treatment (Week 28)
Secondary outcomes (3)
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 16 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test.
Participants were asked to rate their satisfaction level with the results. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Measured: 16 Weeks Post-Final Treatment (Week 28)
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). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain). No anaesthetic was used.
An average of all 4 treatments was taken for each subject.
Measured: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5-point scale. Participants were asked about their tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
An average of all 4 treatments was taken for each subject.
Measured: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start9 May 2019
- Primary completion27 Aug 2021
- Study completion4 Oct 2021
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 Stretch MarkStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097573
- Sponsor's protocol ID
- VI0119
- Status last verified
- Sep 2023
- First submitted
- 4 Oct 2021
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
- ClinicalTrials.gov ID
- NCT05097573
- Acronym / sponsor ID
- VI0119
- Conditions
- Stretch Mark
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Posted 18 Sep 2023
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 prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venus Viva | Experimental | Device: Venus VivaThe Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, male or female subjects, 18-60 years of age who are seeking treatment for their stretch marks
- Fitzpatrick skin type I-IV
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
Key exclusion criteria (14 listed)
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- Subjects with any implantable metal device in the treatment area
- Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
- Current or history of any kind of cancer, or dysplastic nevi in the treated area.
- Severe concurrent conditions, such as cardiac disorders.
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 |
|---|---|---|
| Venus VivaThe Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, stretch marks, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart. | Device | Venus Viva |
Primary outcome
Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment
Time frame: 16 Weeks Post-Final Treatment (Week 28)
Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.
Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS)
Time frame: 16 Weeks Post-Final Treatment (Week 28)
Evaluate the efficacy of overall stretch mark improvement assessed live by the Investigator and a subject assessment of stretch mark including the Global Aesthetic Improvement Scale (GAIS).The Global Aesthetic Improvement Scale is a seven-grade subjective test. The PI evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).
3 secondary outcomes
Subject Satisfaction
Time frame: 16 Weeks Post-Final Treatment (Week 28)
Subject Scale - Visual Analog Scale for Pain
Time frame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Subject Scale - 5 Point Scale for Treatment Tolerability
Time frame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Viva in people with Stretch Mark, run by Venus Concept at 1 site in Switzerland.
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 18 Sep 2023. 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 Switzerland. 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 18 Sep 2023). 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?
Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment (time frame: 16 Weeks Post-Final Treatment (Week 28)). The study lists 2 primary outcomes in all. 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 18 Sep 2023.