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

NCT07187297 | Recruiting FDA Device

• 1 other identifier: TM-PAS-NAPAC-2025-001
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.

  90 days

Secondary Outcomes (1)

• Secondary Endpoint

  180 days

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Treated with Thermage FLX device at day 90

Device: Thermage FLX

Treatment Arm

EXPERIMENTAL

Treated with Thermage FLX device at day 1

Device: Thermage FLX

Interventions

Thermage FLX DEVICE

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

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Mild-to-moderate facial 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 facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)
• Females of childbearing potential must have a negative urine pregnancy test. Females who have experienced menarche and who are not postmenopausal (either confirmed via FSH testing or who have not menstruated for 2 years or more without an alternative medical cause) or surgically sterile will be considered of childbearing potential.
• Females of childbearing potential must agree to use an acceptable method of birth control for the duration of the study. Acceptable methods of birth control are oral and other systemic contraceptives, condoms only, intrauterine device, double-barrier methods, bilateral tubal ligation, partner vasectomy, and abstinence.
• Have no clinically abnormal findings based on the medical history as determined by the study investigator.

You may not qualify if:

• 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.
• Hyaluronic acid filler ≤1 year prior to the screening visit.
• Semi-permanent or permanent fillers at any time prior to the screening visit.
• Plastic surgery within 1 year prior to the screening visit.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Union Square Laser Dermatology

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Sandra Narain

CONTACT

9082428287; sandra.narain@bauschhealth.com

Caitlin Little

CONTACT

caitlin.little@premier-research.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 22, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)