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Trial Outcomes & Findings for A Study of Octave System for Improving Lines and Wrinkles of the Décolleté (NCT NCT04681352)

NCT ID: NCT04681352

Last Updated: 2024-01-18

Results Overview

Improvement in lines and wrinkles of the décolleté were determined after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

Day 90

Results posted on

2024-01-18

Participant Flow

Subjects were recruited from 10 investigational sites in the United States.

Of the 153 screened subjects, 54 subjects exited as screen failures and 99 subjects were enrolled to receive a single Octave-Ultherapy treatment in this study.

Participant milestones

Participant milestones
Measure
Octave-Ultherapy Treatment
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Overall Study
STARTED
99
Overall Study
COMPLETED
75
Overall Study
NOT COMPLETED
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Octave-Ultherapy Treatment
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Overall Study
Lost to Follow-up
2
Overall Study
Withdrawal by Subject
22

Baseline Characteristics

A Study of Octave System for Improving Lines and Wrinkles of the Décolleté

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Octave-Ultherapy Treatment
n=99 Participants
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Age, Continuous
55.9 years
STANDARD_DEVIATION 6.06 • n=5 Participants
Sex: Female, Male
Female
99 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
92 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 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
4 Participants
n=5 Participants
Race (NIH/OMB)
White
94 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 90

Population: Intent-to-treat (ITT) population included all subjects who were enrolled.

Improvement in lines and wrinkles of the décolleté were determined after comparing Day 90 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 90 photographs as "improved" compared to baseline.

Outcome measures

Outcome measures
Measure
Octave-Ultherapy Treatment
n=99 Participants
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
62.2 percentage of subjects

SECONDARY outcome

Timeframe: Day 180

Population: ITT. Here "overall number of subjects analyzed" were subjects who were evaluable for this outcome measure.

Improvement in lines and wrinkles of the décolleté were determined after comparing Day 180 photographs with baseline photographs. Improvement was concluded if at least two evaluators assessed the Day 180 photographs as "improved" compared to baseline.

Outcome measures

Outcome measures
Measure
Octave-Ultherapy Treatment
n=79 Participants
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
68.0 percentage of subjects

SECONDARY outcome

Timeframe: From Day 1 up to end of the study (Up to Day 180)

Population: Safety Population

TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.

Outcome measures

Outcome measures
Measure
Octave-Ultherapy Treatment
n=99 Participants
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
17 Participants

Adverse Events

Octave-Ultherapy Treatment

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Octave-Ultherapy Treatment
n=99 participants at risk
Subjects received a single Ultherapy treatment with the Octave system on Day 1.
Infections and infestations
Covid-19
6.1%
6/99 • From Day 1 up to end of the study (Up to Day 180)
Safety Population. The investigator reported AEs systematically at each visit.

Additional Information

Public Disclosure Manager

Merz Aesthetics

Phone: +1 984-301-3095

Results disclosure agreements

  • Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
  • Publication restrictions are in place

Restriction type: OTHER