Trial Outcomes & Findings for Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring (NCT NCT04827680)

Last Updated: 2023-10-04

Results Overview

Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

12 Weeks Post-Final Treatment

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Overall Study STARTED	20
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=20 Participants 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Age, Continuous	34.7 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks Post-Final Treatment

Outcome measures

Outcome measures
Measure	All Subjects n=10 Participants 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Subject Satisfaction	3.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Average of all treatments

Subject's assessment of discomfort and pain assessed immediately 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).

Outcome measures

Outcome measures
Measure	All Subjects n=20 Participants 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Treatment Pain	4.2 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Average of all treatments

Subject's assessment of treatment tolerability as measured by a 5 point scale. Participants were asked about their treatment tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.

Outcome measures

Outcome measures
Measure	All Subjects n=20 Participants 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Subject Scale - 5 Point Scale for Treatment Tolerability	3.1 units on a scale Standard Deviation 0.4

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=20 participants at risk 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 and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. Venus Viva MD: The Venus Viva™ MD 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, and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart.
Skin and subcutaneous tissue disorders Trauma on chin	5.0% 1/20 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Trauma on forehead	5.0% 1/20 • Number of events 1 • 20 weeks
Skin and subcutaneous tissue disorders Acne and new scars	5.0% 1/20 • Number of events 20 • 20 weeks

Additional Information

Director of Clinical Affairs

Venus Concept

Phone: 888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place