WrinkleNCT07187297
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
A study testing Thermage FLX in people with Wrinkle and Lax Skin, run by Bausch Health Americas, Inc. at 7 sites in United States.
Trial summary
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Lax Skin, Lines Skin
- What is being tested?
- Thermage FLX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
- Be able to follow the study instructions, be available on the specific required study visit days, and be willing to complete all study visit procedures and assessments.
- Understand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment.
- Agree to not undergo excluded procedures (i.e., energy-based device treatments, injectables, or plastic surgery) on the study treatment areas for the duration of study.
- Participant has a body mass index (BMI) ≤30.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Caitlin Little contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Joaninha Barbosa, 617-731-1600 ext. 1625, jdepina@skincarephysicians.net
Jeff Dover
- Recruiting
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
Kevin Zaragoza, 312-245-9965, kzaragoza@chicagodermatology.com
Carolyn Jacob
- Recruiting
Dermatology and Laser Surgery Center
Houston, Texas, 77004
Annie Li, 713-900-3900, research@dermlasersurgery.com
Paul Friedman
- Recruiting
Union Square Laser Dermatology
New York, New York, 10003
Kathyrn Salvador, 212-366-5400, research@unionderm.com
Anne Chapas
- Recruiting
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
Julie Caselli, 916-768-0400, study@skinlasers.com
Suzie Kilmer
- Recruiting
Cosmetic Laser Dermatology
San Diego, California, 92121
Abigail Reyes, 858-657-1004, Abigail.reyes@platinumderm.com
Mitch Goldman
- Recruiting
Cosmetic Laser Dermatology
San Diego, California, 92121
Douglas Wu, 858-657-1002, dwu@clderm.com
Douglas Wu
About this study
Official title: 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
A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
Read the 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.
- Conditions
- Wrinkle, Lax Skin, Lines Skin
- Being tested
- Thermage FLX
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermage FLXDevice
The Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Treated with Thermage FLX device at day 90 Receives: Device: Thermage FLX |
| Treatment Arm | Experimental | Treated with Thermage FLX device at day 1 Receives: Device: Thermage FLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.
Measured: 90 days
Secondary outcomes (1)
Secondary Endpoint
Proportion of participants with any improvement on iGAIS, Fitzpatrick Wrinkle Scale, Facial Laxity Rating Scale, IBSA Inner Upper Arm Laxity Scale, Abdominal Laxity Scale at Day 90 and 180.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start31 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187297
- Sponsor's protocol ID
- TM-PAS-NAPAC-2025-001
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07187297
- Acronym / sponsor ID
- TM-PAS-NAPAC-2025-001
- Conditions
- Wrinkle, Lax Skin, Lines Skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Device: Thermage FLXTreated with Thermage FLX device at day 90 |
| Treatment Arm | Experimental | Device: Thermage FLXTreated with Thermage FLX device at day 1 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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:
- 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)
- 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)
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermage FLXThe Thermage FLX System ('System') is a monopolar, capacitively coupled radiofrequency System designed for use in non-invasive dermatological procedures | Device | Control Arm, Treatment Arm |
Primary outcome
Primary Endpoint
Time frame: 90 days
Proportion of participants with any improvement on iGAIS at Day 90 as assessed by independent blinded evaluators.
1 secondary outcome
Secondary Endpoint
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Wrinkle
Enrolling by invitation
Efficacy of an LED Mask
Fine Lines and Wrinkles, Skin Health
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
Recruiting
Evaluation of the Performance and Safety of the MD60000 Device in the Treatment of Skin Imperfections Due to Aging.
Skin Aging
Recruiting
Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes
Skin Appearance, Skin Texture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Little contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermage FLX in people with Wrinkle and Lax Skin, run by Bausch Health Americas, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Narain (9082428287, sandra.narain@bauschhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.