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A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
NA trial testing Octave-Ultherapy treatment in Décolleté Wrinkles in 99 participants. Completed in 21 February 2022.
| Lead sponsor | Merz North America, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 99 |
| Start date | 29 December 2020 |
| Primary completion | 24 November 2021 |
| Estimated completion | 21 February 2022 |
| Sites | 10 locations across United States |
Merz North America, Inc. — full company profile →
Adults 35 to 65, female only, with Décolleté Wrinkles. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Octave-Ultherapy Treatment | 62.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Octave-Ultherapy Treatment | 68.0 |
TEAEs were defined as adverse events (AEs) with onset or worsening on or after date of first administration of Octave-Ultherapy Treatment.
| Group | Value | 95% CI |
|---|---|---|
| Octave-Ultherapy Treatment | 17 |
Time frame: From Day 1 up to end of the study (Up to Day 180). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Octave-Ultherapy Treatment |
|---|---|---|
| Covid-19 | Infections and infestations | — |
Data from ClinicalTrials.gov NCT04681352 adverse events section.
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing