A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
NCT07187297 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2025-12-17
Summary
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
Conditions
- Wrinkle
- Lax Skin
- Lines Skin
Interventions
- DEVICE
-
Thermage FLX
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2026-06-30
- Completion
- 2027-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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