Décolleté WrinklesNCT04681352
A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
A study testing Octave-Ultherapy treatment in people with Décolleté Wrinkles, run by Merz North America, Inc. at 10 sites in United States.
Trial summary
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Décolleté Wrinkles
- 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
- 99 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Dec 2020to 21 Feb 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.
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.
- Breast implants or is planning to receive breast implants during the study.
- Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Merz Investigational Site #0010395
Beverly Hills, California, 90210
Merz Investigational Site #0010346
Chicago, Illinois, 60611
Merz Investigational Site #0010416
Miami, Florida, 33137
Merz Investigational Site #0010439
New York, New York, 10022
Merz Investigational Site #0010452
New York, New York, 10075
Merz Investigational Site #0010352
Norwalk, Connecticut, 06851
Merz Investigational Site #0010125
Plano, Texas, 75093
Merz Investigational Site #0010321
San Mateo, California, 92121
Merz Investigational Site #0010392
Spokane, Washington, 99202
Merz Investigational Site #0010396
Wilmington, North Carolina, 28403
About this study
Official title: Prospective, Evaluator-blind, Multicenter Study to Assess the Safety and Effectiveness of Treatment With the Octave System for Improving Lines and Wrinkles of the décolleté
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
- Conditions
- Décolleté Wrinkles
- 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-focused ultrasound delivered below the surface of the skin.
| Study group | Role | What they receive |
|---|---|---|
| Octave System | Experimental | Single treatment of décolleté tissue. 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 Improvement in Lines and Wrinkles of the Décolleté at Day 90
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.
Measured: Day 90
Secondary outcomes (2)
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
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.
Measured: Day 180
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
Measured: From Day 1 up to end of the study (Up to Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start29 Dec 2020
- Primary completion24 Nov 2021
- Study completion21 Feb 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 Décolleté WrinklesStudies 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
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ulthera, Inc
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681352
- Sponsor's protocol ID
- M960101003
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2020
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 18 Jan 2024. 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 Improving Lines and Wrinkles of the décolleté
- ClinicalTrials.gov ID
- NCT04681352
- Acronym / sponsor ID
- M960101003
- Conditions
- Décolleté Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ulthera, Inc
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Octave System | Experimental | Device: Octave-Ultherapy treatmentSingle treatment of décolleté tissue. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe fine lines, wrinkles, laxity, and crepiness of the décolleté that is amenable to improvement with non-invasive intervention and is not severe enough for surgical intervention.
Key exclusion criteria (5 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.
- Breast implants or is planning to receive breast implants during the study.
- Inability to take pre-treatment medications due to a pre-existing condition, medication allergy, or medical issue that, at the discretion of the treating investigator, is contraindicated.
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-focused ultrasound delivered below the surface of the skin. | Device | Octave System |
Primary outcome
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90
Time frame: Day 90
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.
2 secondary outcomes
Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180
Time frame: Day 180
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Day 1 up to end of the study (Up to Day 180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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A Study Assessing KB304 for the Treatment of Wrinkles in Women
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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.
10 sites in 1 country: 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 Décolleté Wrinkles, run by Merz North America, Inc. at 10 sites in United States.
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 1 inclusion and 5 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 21 Dec 2023). 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 Improvement in Lines and Wrinkles of the Décolleté 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 18 Jan 2024.