High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity

This is an interventional treatment trial for Skin Laxity Read More

Inclusion Criteria:

a) Male or female subjects > 35 years of age and < 70 years of age b) Subjects in good general health based on investigator's judgment and medical history c) Upper inner arm skin laxity that improves when the skin of the upper inner arm is stretched or lifted superiorly d) Moderate to severe upper inner arm skin crepiness/laxity based on the Upper Inner Arm Visual Crepiness/Laxity Grading Scale (Appendix B) e) Must be willing to give and sign an informed consent form and photographic release form f) Must have a stable body weight for at least six (6) months prior to study entry g) Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study h) Must agree to avoid tanning or use of sunless tanner during the entire course of the study i) Negative urine pregnancy test result at the time of study entry (if applicable) j) For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

1. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
2. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

k) Must be willing to comply with study treatments and complete the entire course of the study

Exclusion Criteria:

1. Liposuction to bilateral upper arms during the 12-month period prior to study treatment or any time during the course of the study
2. Mesotherapy; dermal fillers, biostimulatory injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery (i.e., brachyplasty) during the 12-month period before study treatment
3. Any investigational treatment of skin crepiness/laxity of the upper arms during the 12-month period before the study treatment
4. Creams/cosmeceuticals and/or home therapies to prevent or treat skin laxity during the four-week period before study treatment
5. Subjects with scarring in the treatment areas
6. History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral upper extremities
7. Any history of bleeding or coagulation disorders
8. Subjects with tattoos or permanent implants in the treatment areas
9. Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
10. Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
11. Subjects with an active bacterial, viral, or fungal infection of the treatment areas
12. Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
13. History of lidocaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
14. Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
15. Presence of incompletely healed wound(s) in the treatment area
16. Subject who is on an immunosuppressant or has an autoimmune condition
17. Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
18. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study