Up to 25 subjects will be enrolled and randomized. Randomized subjects will receive one single-side Ulthera® treatment in the pre-auricular region on the face. At each subject's scheduled facelift procedure, resected tissue will be obtained for analysis.
This is a prospective, multi-center, pilot clinical trial to evaluate the molecular changes following an Ultherapy® treatment. Subjects will be randomized to one of five treatment groups and, based on study group assignment, will receive one single-side Ultherapy® treatment at varying timepoints prior to an already planned facelift procedure. Treatment will be delivered to the pre-auricular region on one side of the face; the contralateral side will serve as control. During an already planned facelift procedure, treated and non-treated resected tissue will be obtained for analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
16
Focused ultrasound energy delivered below the surface of the skin.
North Valley Plastic Surgery
Phoenix, Arizona, United States
Campbell Facial Plastic Surgery
Mequon, Wisconsin, United States
Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling
RNA will be extracted from treated and untreated (control) tissue samples obtained from 15 study subjects. For each subject tissue of the contra-lateral side of the face served as a control and will not receive Ultherapy treatment. OneArray Human Gene Expression microarray will be used for microarray profiling. Clustering Analysis will be performed to identify differences between treated vs. control samples and the up and down-regulated genes will be represented in a heatmap. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
Changes in Gene Expression of Apoptotic Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 genes related to apoptosis (e.g. Annexin V, Caspacin, TNF ligands and their receptors, members of the bcl-2, caspase, IAP, TRAF, CARD, death domain, death effector domain, and CIDE families, as well as genes involved in the p53 and DNA damage pathways) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
Changes in Gene Expression of Heat Shock Proteins Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array
Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 Heat Shock Protein genes that regulate protein folding (e.g. HSP90 (81 to 99 kD), HSP70 (65 to 80 kD), HSP60 (55 to 64 kD), HSP40 (35 to 54 kD), small HSPs (=34 kD) and other chaperone cofactors) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment
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Changes in Protein Expression in Tissues Treated With Ultherapy Compared to Control (Untreated) Tissue by Immunohistochemistry
Protein expression of apoptotic genes and heat shock proteins of interest identified in the three previous outcomes will be analyzed. Embedded or frozen section tissues will be stained for specific proteins previously identified. The number of subjects with differentially expressed proteins in treated samples compared to control samples will be determined for every study group.
Time frame: 1-3 hours to up to 45 days following Ultherapy treatment