CompletedNCT03467724Updated Jul 29, 2024Results posted

Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift

An interventional study of Fractional Radiofrequency (FRF) in Surgical Scar, Breast Augmentation and Abdominoplasty, sponsored by Venus Concept. Completed at 1 site in Spain. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.

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

Phase: Not applicable
Study type: Interventional
Enrollment: 54
Allocation: Not applicable
Ages: 20 Years to 75 Years
Sex: All

Study 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. 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 studied

Surgical Scar
Breast Augmentation
Abdominoplasty
Face Lift

Keywords

Fractional Radiofrequency

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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).
  1. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
  1. 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.
  1. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
  1. Poorly controlled endocrine disorders, such as diabetes. 12. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
  1. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
  1. 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.
  1. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 54 participants (actual)

Study arms

Experimental
Fractional radiofrequency (FRF)
Subjects received 3 FRF treatments (monthly) over their scar following breast augmentation, abdominoplasty or face lift surgery.
Device: Fractional Radiofrequency (FRF)

Interventions

DeviceFractional Radiofrequency (FRF)
Fractional radiofrequency will be delivered to the area of the surgical scar.

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
Time frame: 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.
Time frame: 12 months

Results

Posted Jul 29, 2024

Participant flow

Participant flow — Overall Study
Milestone	FRF Treatment
Started	51
Completed	43
Not completed	8
Withdrew: Lost to follow-up	5
Withdrew: Withdrawal by subject	1
Withdrew: Protocol violation	1
Withdrew: Adverse event	1

Outcome measures

PrimaryImprovement 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
Reported as:: Mean · units on a scale

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).
units on a scale	FRF Treatment
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).	1.66 ± 0.71

SecondaryAssessment 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.

Time frame:: 12 months
Reported as:: Mean · units on a scale

Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.
units on a scale	10 Months After FRF Treatment	Baseline
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.	13.4 ± 1.2	28.3 ± 1.4

SecondarySubject 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.

Time frame:: 12 months
Reported as:: Mean · units on a scale

Subject Satisfaction With Treatment
units on a scale	FRF Treatment
Subject Satisfaction With Treatment	3.4 ± 1.0

Adverse events

Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FRF Treatment	0/51 (0%)	0/51 (0%)	3/51 (5.9%)

Most frequent other events

Most frequent other events
Event	FRF Treatment
Wound Healing Disorder (post-op)Skin and subcutaneous tissue disorders	2/51
Enlargement of ScarSkin and subcutaneous tissue disorders	1/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)	FRF Treatment
Mean	47.5 ± 0.2

Sex: Female, Male
Sex: Female, Male(Participants)	FRF Treatment
Female	47
Male	4

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	FRF Treatment
Mediterranean	19
Eastern European	5
Western European	22
Brazilian (White&Black)	1
Black	1
Central & South American	2
Iranian	1

Study locations

1 site

Ocean Clinic
Marbella, Spain

References and documents

Study documents

Protocol and statistical analysis plan · Feb 7, 2018

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03467724
Lead sponsor: Venus Concept
Responsible party: Sponsor
First posted: Mar 16, 2018
Start date: Jan 23, 2018
Primary completion: Apr 13, 2020
Completion: Apr 13, 2020
Results posted: Jul 29, 2024
Last update: Jul 29, 2024

Study contacts

Kai O. Kaye

principal investigator · Ocean Clinic

Oversight

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

View the source record on ClinicalTrials.gov ↗

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