A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

Part of paid clinical trials in New York, New York.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT07187297
Status
Recruiting
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Conditions

  • Lax Skin
  • Lines Skin
  • Wrinkle

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Thermage FLX — DEVICE
    The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures

Study Details

A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System

Key Dates

Start date
Oct 31, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Active Comparator: Control Arm
    Treated with Thermage FLX device at day 90
  • Experimental: Treatment Arm
    Treated with Thermage FLX device at day 1

Primary Outcome Measure

Primary Endpoint [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Union Square Laser DermatologyNew YorkNew York10003

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By research site
Union Square Laser Dermatology· New York, NY

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