Surgical ScarNCT03467724
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
A study testing Fractional Radiofrequency (FRF) in people with Surgical Scar and Breast Augmentation, run by Venus Concept at 1 site in Spain.
Trial summary
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Scar, Breast Augmentation, Abdominoplasty
- What is being tested?
- Fractional Radiofrequency (FRF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2018to 13 Apr 2020
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, female, subjects 20-60 years of age who are seeking treatment for their breast augmentation or abdominoplasty surgical scars or male and female patients 40-75 years of age who are seeking treatment for their face lift surgical scars.
- A minimum of four weeks since surgery.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Willing to avoid direct sunlight for the duration of the study.
- Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.
Who cannot join
- 1. Fitzpatrick skin types 5-6. 2. Implantable defibrillators, cardiac pacemakers, and other metal implants 3. Subjects with any implantable metal device in the treatment area 4. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- 5. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- 6. Current or history of any kind of cancer, or pre-malignant moles. 7. Severe concurrent conditions, such as cardiac disorders. 8. Pregnancy or intending to become pregnant during the study and nursing. 9. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- 10. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- 11. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
- 13. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
- 14. History of bleeding coagulopathies, or use of anticoagulants. 15. Use of isotretinoin (Accutane®) within six months prior to treatment. 16. Treating over tattoo or permanent makeup. 17. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- 18. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. Subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. Subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Being tested
- Fractional Radiofrequency (FRF)
- Keywords
- Fractional Radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Radiofrequency (FRF)Device
Fractional radiofrequency will be delivered to the area of the surgical scar.
| Study group | Role | What they receive |
|---|---|---|
| Fractional radiofrequency (FRF) | Experimental | Subjects received 3 FRF treatments (monthly) over their scar following breast augmentation, abdominoplasty or face lift surgery. Receives: Device: Fractional Radiofrequency (FRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse).
Measured: 12 months
Secondary outcomes (2)
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
Patient and Observer Scar Assessment Scale (POSAS) was used to evaluate the scar for pain, itching, color, stiffness, thickness, and appearance compared to their normal skin using a numbered scale. The scale ranges from 7 (no scar) to 70 with higher scores being worse and suggesting a worse scar.
Measured: 12 months
Subject Satisfaction With Treatment
Subjects will use the 5-point Likert Satisfaction scale where 4 is very satisfied, 3 is satisfied, 2 is having no opinion, 1 is unsatisfied and 0 is very unsatisfied to evaluate their satisfaction with the treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start23 Jan 2018
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
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 Surgical ScarStudies 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
- The subject will act as their own control. Each surgical scar will be compared at the 12-month follow-up to the pre-treatment baseline.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai O. Kaye, Principal investigator, Ocean Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467724
- Sponsor's protocol ID
- CS0717
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2018
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of Fractional RF for the Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
- ClinicalTrials.gov ID
- NCT03467724
- Acronym / sponsor ID
- CS0717
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Keywords
- Fractional Radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift. The study will enroll up to 50 female subjects requesting treatment of surgical scars following breast augmentation or abdominoplasty and up to 25 male and female subjects requesting treatment of surgical scars following facelift surgery. Subjects will receive a total of 3 treatments of their surgical scars at 1-month intervals. Subjects will be followed up at 10 months after their last treatment (12 months after the first treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subject will act as their own control. Each surgical scar will be compared at the 12-month follow-up to the pre-treatment baseline.
| Arm | Type | Receives |
|---|---|---|
| Fractional radiofrequency (FRF) | Experimental | Device: Fractional Radiofrequency (FRF)Subjects received 3 FRF treatments (monthly) over their scar following breast augmentation, abdominoplasty or face lift surgery. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, female, subjects 20-60 years of age who are seeking treatment for their breast augmentation or abdominoplasty surgical scars or male and female patients 40-75 years of age who are seeking treatment for their face lift surgical scars.
- A minimum of four weeks since surgery.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Willing to avoid direct sunlight for the duration of the study.
Key exclusion criteria (8 listed)
- 1. Fitzpatrick skin types 5-6. 2. Implantable defibrillators, cardiac pacemakers, and other metal implants 3. Subjects with any implantable metal device in the treatment area 4. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
- 5. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
- 6. Current or history of any kind of cancer, or pre-malignant moles. 7. Severe concurrent conditions, such as cardiac disorders. 8. Pregnancy or intending to become pregnant during the study and nursing. 9. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
- 10. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
- 11. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
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 |
|---|---|---|
| Fractional Radiofrequency (FRF)Fractional radiofrequency will be delivered to the area of the surgical scar. | Device | Fractional radiofrequency (FRF) |
Primary outcome
Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse).
Time frame: 12 months
2 secondary outcomes
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
Time frame: 12 months
Subject Satisfaction With Treatment
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kai O. Kaye principal investigator
Ocean Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Radiofrequency (FRF) in people with Surgical Scar and Breast Augmentation, run by Venus Concept at 1 site in Spain.
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 6 inclusion and 8 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 29 Jul 2024. 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 Spain. 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 29 Jul 2024). 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?
Improvement of Surgical Scars at 12 Months Compared to Baseline (Pre-treatment) as Evaluated by 3 Independent Blinded Reviewers Using the General Aesthetic Improvement Scale (GAIS). The GAIS Ranges From 3 (Very Much Improved) to -3 (Very Much Worse). (time frame: 12 months). 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 29 Jul 2024.