Status:
COMPLETED
A Study of Octave System for Improving Lines and Wrinkles of the Décolleté
Lead Sponsor:
Merz North America, Inc.
Collaborating Sponsors:
Ulthera, Inc
Conditions:
Décolleté Wrinkles
Eligibility:
FEMALE
35-65 years
Phase:
NA
Brief Summary
To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04681352
Start Date
December 29 2020
End Date
February 21 2022
Last Update
January 18 2024
Active Locations (10)
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1
Merz Investigational Site #0010395
Beverly Hills, California, United States, 90210
2
Merz Investigational Site #0010321
San Mateo, California, United States, 92121
3
Merz Investigational Site #0010352
Norwalk, Connecticut, United States, 06851
4
Merz Investigational Site #0010416
Miami, Florida, United States, 33137