Trial Outcomes & Findings for Gene Expression Following Ultherapy® Treatment (NCT NCT02441036)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

1-3 hours to up to 45 days following Ultherapy treatment

Results posted on

2019-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	1-3 Hours Before Resection Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection	1 Day Before Resection Subjects will receive Ultherapy treatment 1 day prior to tissue resection	3 Days Before Resection Subjects will receive Ultherapy treatment 3 days prior to tissue resection	7 Days Before Resection Subjects will receive Ultherapy treatment 7 days prior to tissue resection	45 Days Before Resection Subjects will receive Ultherapy treatment 45 days prior to tissue resection
Overall Study STARTED	3	5	3	4	1
Overall Study Treated	3	5	3	4	1
Overall Study Tissue Resected	3	4	3	3	1
Overall Study COMPLETED	3	4	3	3	1
Overall Study NOT COMPLETED	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1-3 Hours Before Resection Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection	1 Day Before Resection Subjects will receive Ultherapy treatment 1 day prior to tissue resection	3 Days Before Resection Subjects will receive Ultherapy treatment 3 days prior to tissue resection	7 Days Before Resection Subjects will receive Ultherapy treatment 7 days prior to tissue resection	45 Days Before Resection Subjects will receive Ultherapy treatment 45 days prior to tissue resection
Overall Study No tissue resected	0	1	0	1	0

Baseline Characteristics

Gene Expression Following Ultherapy® Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1-3 Hours Before Resection n=3 Participants Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection	1 Day Before Resection n=5 Participants Subjects will receive Ultherapy treatment 1 day prior to tissue resection	3 Days Before Resection n=3 Participants Subjects will receive Ultherapy treatment 3 days prior to tissue resection	7 Days Before Resection n=4 Participants Subjects will receive Ultherapy treatment 7 days prior to tissue resection	45 Days Before Resection n=1 Participants Subjects will receive Ultherapy treatment 45 days prior to tissue resection	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	12 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants
Age, Continuous	51.5 years n=5 Participants	58.9 years n=7 Participants	65.3 years n=5 Participants	60.0 years n=4 Participants	63.3 years n=21 Participants	59.3 years n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	15 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	4 participants n=4 Participants	1 participants n=21 Participants	16 participants n=8 Participants

PRIMARY outcome

Timeframe: 1-3 hours to up to 45 days following Ultherapy treatment

Population: Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1-3 hours to up to 45 days following Ultherapy treatment

Population: Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1-3 hours to up to 45 days following Ultherapy treatment

Population: Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1-3 hours to up to 45 days following Ultherapy treatment

Population: Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.

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.