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Tests treatment safety and results for Wrinkle
Official title A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
ClinicalTrials.gov ID: NCT07187297
What this study is testing
- What it's testing
- A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60. Healthy volunteers may be eligible.
You may be able to join 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...
- 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)
You likely can't join 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...
- 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).
See the full eligibility 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:
- 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.