Eyebrow LiftLIFT-ENCT05067504
Effectiveness and Safety of the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
A study testing Octave-Ultherapy treatment in people with Eyebrow Lift and Improved Appearance of the Face and Neck, run by Merz North America, Inc. at 3 sites in 2 countries.
Trial summary
This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Eyebrow Lift, Improved Appearance of the Face and Neck
- What is being tested?
- Octave-Ultherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 May 2021to 14 Nov 2022
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate eyebrow/upper-face laxity.
- Mild to moderate fine lines, wrinkles, and laxity of the face and neck.
Who cannot join
- Presence of an active systemic or local skin disease that may affect wound healing.
- Scarring in area(s) to be treated.
- Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Merz Investigational Site #0010101
Coral Gables, Florida, 33146
Merz Investigational Site #0010358
Vista, California, 92083
About this study
Official title: Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck.
- Being tested
- Octave-Ultherapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octave-Ultherapy treatmentDevice
Micro-focussed ultrasound delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Octave-Ultherapy treatment | Experimental | Octave-Ultherapy treatment of the brow, face, and neck. Receives: Device: Octave-Ultherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treated Subjects With Eyebrow Lift at Day 90
Improvement in eyebrow lift was determined by three evaluators after comparing Day 90 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 90 photographs as compared to baseline.
Measured: Day 90
Secondary outcomes (6)
Percentage of Treated Subjects With Eyebrow Lift at Day 180
Improvement in eyebrow lift was determined by three evaluators after comparing Day 180 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 180 photographs as compared to baseline.
Measured: Day 180
Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180
Eyebrow lift position on frontal view was measured by calculating the differences in eyebrow height. Standard images of the subject's face were collected before treatment, and at Day 90 and Day 180 to visualize and quantify changes in the treated regions.
Measured: Day 90 and Day 180
Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject
The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Forehead and Eyebrows module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome).
Measured: At Baseline, Day 90 and Day 180
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject
The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. The subject assessed satisfaction using the Face-Q Satisfaction with Lower Face and Jawline module (1 [very dissatisfied] to 4 [very satisfied] scores; Rasch transformed score 0-100; higher scores meant better outcome).
Measured: At Baseline, Day 90 and Day 180
Change From Baseline in FACE-Q Patient-Perceived Age Visual Analogue Scale (VAS) Rating at Day 90 and Day 180, as Assessed by the Subject
For the FACE-Q Patient-perceived Age VAS, subjects were asked a question "How many years younger or older do you think you look compared with your actual age?". Perception of age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome).
Measured: At Baseline, Day 90 and Day 180
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
Measured: From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start24 May 2021
- Primary completion17 Aug 2022
- Study completion14 Nov 2022
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 Eyebrow LiftStudies 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
- All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067504
- Sponsor's protocol ID
- M960101001
- Acronym
- LIFT-E
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2021
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Lifting the Eyebrow and Improving the Appearance of the Face and Neck
- ClinicalTrials.gov ID
- NCT05067504
- Acronym / sponsor ID
- LIFT-E / M960101001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to evaluate the effectiveness and safety of the Octave System to lift the eyebrow and improve the appearance of the face and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects will receive a single Octave-Ultherapy treatment of the brow, face, and neck.
| Arm | Type | Receives |
|---|---|---|
| Octave-Ultherapy treatment | Experimental | Device: Octave-Ultherapy treatmentOctave-Ultherapy treatment of the brow, face, and neck. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate eyebrow/upper-face laxity.
- Mild to moderate fine lines, wrinkles, and laxity of the face and neck.
Key exclusion criteria (3 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- Scarring in area(s) to be treated.
- Active implants (e.g., pacemakers or defibrillators), ports, or metallic implants in area(s) to be treated.
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 |
|---|---|---|
| Octave-Ultherapy treatmentMicro-focussed ultrasound delivered below the surface of the skin. | Device | Octave-Ultherapy treatment |
Primary outcome
Percentage of Treated Subjects With Eyebrow Lift at Day 90
Time frame: Day 90
Improvement in eyebrow lift was determined by three evaluators after comparing Day 90 photographs with baseline photographs. Lift was concluded if at least two evaluators reported "eyebrow lift" in the Day 90 photographs as compared to baseline.
6 secondary outcomes
Percentage of Treated Subjects With Eyebrow Lift at Day 180
Time frame: Day 180
Percentage of Treated Subjects With Eyebrow Lift of at Least 0.5 Millimeter (mm) at Day 90 and Day 180
Time frame: Day 90 and Day 180
Change From Baseline in FACE-Q Satisfaction With Forehead and Eyebrows Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject
Time frame: At Baseline, Day 90 and Day 180
Change From Baseline in FACE-Q Satisfaction With Lower Face and Jawline Score (Rasch-transformed) at Day 90 and Day 180, as Assessed by Subject
Time frame: At Baseline, Day 90 and Day 180
Change From Baseline in FACE-Q Patient-Perceived Age Visual Analogue Scale (VAS) Rating at Day 90 and Day 180, as Assessed by the Subject
Time frame: At Baseline, Day 90 and Day 180
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Octave-Ultherapy Treatment
Time frame: From first treatment on Day 1 up to the end of study on Day 180 (an average of 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Merz Medical Expert study director
Merz North America, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octave-Ultherapy treatment in people with Eyebrow Lift and Improved Appearance of the Face and Neck, run by Merz North America, Inc. at 3 sites in 2 countries.
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 2 inclusion and 3 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Puerto Rico. 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 15 Oct 2025). 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?
Percentage of Treated Subjects With Eyebrow Lift at Day 90 (time frame: Day 90). 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 15 Oct 2025.