A Study of Octave System for Improving Lines and Wrinkles of the Décolleté

Merz Pharmaceuticals

Status: Completed

Conditions: Décolleté Wrinkles

Treatments: Device: Octave-Ultherapy treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04681352

M960101003

Details and patient eligibility

About

To demonstrate the safety and effectiveness of the Octave System for improving lines and wrinkles of the décolleté.

Enrollment: 99 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Octave System

Experimental group

Description:

Single treatment of décolleté tissue.

Treatment:

Device: Octave-Ultherapy treatment