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

Part of paid clinical trials in Sacramento, California.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT07187297
Status
Recruiting
Apply to this trial

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

First listed
Sep 22, 2025
Start date
Oct 31, 2025
Status verified
Aug 2026
Primary completion
Feb 28, 2027
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 (7)

FacilityCityStateZIPSite coordinators
Laser & Skin Surgery Center of Northern CaliforniaSacramentoCalifornia95816
Julie Caselli
[email protected]
916-768-0400
Suzie Kilmer (PRINCIPAL_INVESTIGATOR)
Cosmetic Laser DermatologySan DiegoCalifornia92121
Abigail Reyes
[email protected]
858-657-1004
Mitch Goldman (PRINCIPAL_INVESTIGATOR)
Cosmetic Laser DermatologySan DiegoCalifornia92121
Douglas Wu
[email protected]
858-657-1002
Douglas Wu (PRINCIPAL_INVESTIGATOR)
Chicago Cosmetic Surgery and DermatologyChicagoIllinois60654
Kevin Zaragoza
[email protected]
312-245-9965
Carolyn Jacob (PRINCIPAL_INVESTIGATOR)
SkinCare PhysiciansChestnut HillMassachusetts02467
Joaninha Barbosa
[email protected]
617-731-1600
Jeff Dover (PRINCIPAL_INVESTIGATOR)
Union Square Laser DermatologyNew YorkNew York10003
Kathyrn Salvador
[email protected]
212-366-5400
Anne Chapas (PRINCIPAL_INVESTIGATOR)
Dermatology and Laser Surgery CenterHoustonTexas77004
Annie Li
[email protected]
713-900-3900
Paul Friedman (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
Laser & Skin Surgery Center of Northern California· Sacramento, CACosmetic Laser Dermatology· San Diego, CAChicago Cosmetic Surgery and Dermatology· Chicago, ILSkinCare Physicians· Chestnut Hill, MAUnion Square Laser Dermatology· New York, NYDermatology and Laser Surgery Center· Houston, TX

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