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RECRUITINGNA

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

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face

NCT07187297•Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

Study to be conducted at approximately 10 study centers, enrolling a total of 164 participants in North America (US and Canada) and China. Approximately 6 months (26 weeks) Purpose is to demonstrate superiority of treatment with the Thermage FLX System compared to untreated control for the improvement of: Lines and wrinkles of the neck and face Skin laxity of the neck, abdomen, upper arms, and face and evaluate safety and tolerability of treatment with the Thermage FLX System compared to the untreated control arm.

Eligibility

Age

30 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Be an adult female or male, ≥30 - ≤60 years of age.
•Have mild-to-moderate skin laxity of the neck, abdomen, upper arms, and/or face, and/or mild-to-moderate lines and/or wrinkles of the neck and/or face assessed as follows:
•Neck:
•Mild-to-moderate neck skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)
•Mild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)
•Abdomen:
•Mild-to-moderate abdomen skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0-3)
•Upper arms:
•Mild to moderate upper arms skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale
•Face:
+9 more criteria

Exclusion Criteria

•Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study.
•Participant has given birth within 3 months prior to the screening visit.
•Participant has an anticipated need for procedures, surgery, overnight hospitalization, or other events that would prevent the participant from making the required visits during the study.
•Participant has a pacemaker, internal defibrillator, or other implanted electronic device.
•Participant has an implant in the target treatment zone(s).
•Participant has had radiation therapy in the target treatment zone(s).
•Participant has had 1 or more prior cosmetic procedures in the target treatment zone(s) including:
•Thermage or any energy-based device procedure, derm abrasion, or chemical peel on any treatment area within 6 months prior to the screening visit.
•Short-acting neurotoxins within 6 months prior to the screening visit.
•Long-acting neurotoxins within 9 months prior to the screening visit.
+3 more criteria

Locations (1)

Union Square Laser Dermatology

New York, New York, United States

Key Dates

Start Date

October 31, 2025

Primary Completion Date

June 1, 2026

Completion Date

March 1, 2027

Last Updated

December 17, 2025

Enrollment

164

ESTIMATED participants

Conditions

WrinkleLax SkinLines Skin

Interventions

Thermage FLX

DEVICE

Contacts

Sandra Narain

CONTACT

9082428287 sandra.narain@bauschhealth.com

Caitlin Little

CONTACT

caitlin.little@premier-research.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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