Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face
Conditions
Interventions
Control Group:On the 90th day, underwent Thermage FLX treatment in one or more treatment areas (Area 1, neck
Area 2, abdomen
Area 3, upper arm
Area 4, face)
Treatment Group:On the 1st day, underwent Thermage FLX treatment in one or more treatment areas (Area 1, neck
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Be an adult female or male, 30 – 60 years of age; 2. Have mild-to-moderate skin laxity of the face, neck, abdomen, and/or upper arms, and/or mild-to-moderate lines and/or wrinkles of the face and/or neck assessed as follows: (1) Neck: 1) 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); 2) Mild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0–9); (2) Abdomen: 1) Mild-to-moderate abdominal skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0–3); (3) Upper arms: 1) Mild-to-moderate upper arm skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale; (4) Face: 1) 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); 2) Mild-to-moderate facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0–9); 3. Females of childbearing potential, defined as having experienced menarche and not undergone successful surgical sterilization or not having been post-menopausal for more than 2 years, must have a negative urine pregnancy test; 4. 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; 5. Have no clinically abnormal findings based on the medical history as determined by the study investigator; 6. 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; 7. Understand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment; 8. 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; 9. Participant has a body mass index (BMI) <=30 kg/m^2.
Exclusion criteria
Exclusion criteria: 1. Participant is pregnant or breastfeeding or planning to become pregnant within 3 months prior to or during the study. 2. Participant has given birth within 3 months prior to the screening visit. 3. Participant has an anticipated need for procedures, surgery, overnight hospitalization, or other conditions that would prevent the participant from completing required study visits during the study period. 4. Participant has a pacemaker, internal defibrillator, or other implanted electronic device. 5. Participant has an implant in the target treatment zone(s). 6. Participant has received radiation therapy in the target treatment zone(s). 7. Participant has a history of prior cosmetic procedures in the target treatment zone(s), including: (1) Thermage or any energy-based device procedure, dermabrasion, or chemical peel on any treatment area within 6 months prior to the screening visit; (2) Treatment with short-acting neurotoxins within 6 months prior to the screening visit; (3) Treatment with long-acting neurotoxins within 9 months prior to the screening visit; (4) Hyaluronic acid filler injection within 1 year prior to the screening visit; (5) Semi-permanent or permanent filler treatment at any time prior to the screening visit; (6) Plastic surgery within 1 year prior to the screening visit. 8. Participant has excessive subcutaneous fat in the target treatment zone(s). 9. Participant has a tattoo in any target treatment zone(s). 10. Participant has active localized infection in the target treatment zone(s) or uncontrolled systemic infection. 11. Participant has any of the following pre-existing skin conditions in the target treatment zone(s): eczema, psoriasis, allergic dermatitis, severe acne, rosacea, or other skin disorders that may interfere with the study treatment. 12. Participants with tanned or sunburned skin in the target treatment zone(s) at the screening and/or baseline visit may be excluded at the investigator’s discretion. 13. Participant has medical conditions affecting collagen synthesis, including Ehlers-Danlos syndrome and scleroderma. 14. Participant has a diagnosis of diabetes or a history of congestive heart disease. 15. Participant has rheumatologic or autoimmune diseases. 16. Participant has photosensitive conditions or is taking medications containing aminolevulinic acid (e.g., Levulan). 17. Participant has any medical condition, including abnormal or extensive skin surface irregularities, that may compromise the safe completion of the study protocol. 18. Participant has applied topical retinoid creams/ointments or vitamin creams (Vitamin A, C, or E, including retinol and other retinoids) to the target treatment zone(s) within 2 weeks prior to the baseline visit. 19. Participant has used oral isotretinoin (Accutane) within 6 months prior to the screening visit. 20. Participant has excessive hair in the target treatment zone(s) (e.g., beard or mustache) and refuses to shave it off. 21. Any other conditions that, in the investigator’s judgment, render the participant unsuitable for study treatment or may interfere with study results. 22. Participant has a history of thyroid or parathyroid disorders. 23. Participant has allergies to topical or injectable anesthetics. 24. Participant has taken weight-loss medications (e.g., oral or injectable anti-obesity drugs, systemic steroids) within 3 months prior to the screening visit. 25. Participant has medical conditions that may cause significant body weight fluctuations (e.g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of subjects who showed any improvement in the iGAIS score on the 90th day. The variable is the iGAIS score of each subject as assessed independently and blindly by the evaluato; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with any improvement on iGAIS at Day 180 as assessed by independent blinded evaluators.;For abdomen: Improvement on the abdominal skin laxity scale at Day 90 and Day 180;Proportion of participants with any improvement on sGAIS at Day 90 and Day 180.;For face and neck: Improvement on Fitzpatrick Wrinkle Scale at Day 90 and Day 180;For face and neck: Improvement on Facial Laxity Rating Scale at Day 90 and Day 180;For upper arm: Improvement on IBSA Inner Upper Arm Laxity Scale at Day 90 and Day 180; | — |
Countries
China
Contacts
Public ContactLeihong Xiang
Huashan Hospital, Fudan University
Outcome results
None listed