N/A
Completed N=99
A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
Décolleté Wrinkles
Source: ClinicalTrials.gov NCT04681352 ↗
Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 — 62.2 percentage of subjects
Summary
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90 |
62.2 | — |
| SECONDARY Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 180 |
68.0 | — |
| SECONDARY Number of Subjects With Treatment-emergent Adverse Events (TEAEs) |
17 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04681352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.