Trial Outcomes & Findings for Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift (NCT NCT03467724)

NCT ID: NCT03467724

Last Updated: 2024-07-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-07-29

Participant Flow

3 subjects failed screening and were not treated in the study.

Participant milestones

Measure	FRF Treatment Each subject received 3 VivaMD treatments (monthly).
Overall Study STARTED	51
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	FRF Treatment Each subject received 3 VivaMD treatments (monthly).
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FRF Treatment n=51 Participants Each subject received 3 VivaMD treatments (monthly).
Age, Continuous	47.5 years STANDARD_DEVIATION 0.2 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Mediterranean	19 Participants n=5 Participants
Race/Ethnicity, Customized Eastern European	5 Participants n=5 Participants
Race/Ethnicity, Customized Western European	22 Participants n=5 Participants
Race/Ethnicity, Customized Brazilian (White&Black)	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Central & South American	2 Participants n=5 Participants
Race/Ethnicity, Customized Iranian	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	FRF Treatment n=43 Participants Each subject received 3 VivaMD treatments (monthly).	Baseline Before 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 units on a scale Standard Deviation 0.71	—

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	FRF Treatment n=43 Participants Each subject received 3 VivaMD treatments (monthly).	Baseline n=43 Participants Before treatment
Assessment of Surgical Scars at 12 Months as Evaluated by the Patients.	13.4 units on a scale Standard Error 1.2	28.3 units on a scale Standard Error 1.4

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	FRF Treatment n=43 Participants Each subject received 3 VivaMD treatments (monthly).	Baseline Before treatment
Subject Satisfaction With Treatment	3.4 units on a scale Standard Deviation 1.0	—

Adverse Events

FRF Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FRF Treatment n=51 participants at risk Each subject received 3 VivaMD treatments (monthly).
Skin and subcutaneous tissue disorders Wound Healing Disorder (post-op)	3.9% 2/51 • Number of events 2 • 10 months
Skin and subcutaneous tissue disorders Enlargement of Scar	2.0% 1/51 • Number of events 1 • 10 months

Additional Information

Director of Clinical Affairs

Venus Concept

Phone: 1-888-907-0115

Email: mgronski@venusconcept.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place