Gene Expression Following Ultherapy® Treatment

NCT02441036 | Terminated Results FDA Device

• 1 other identifier: ULT-140
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Skin Laxity

Keywords

Gene expression and protein production

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

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

• 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.

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

Study Arms (5)

Group 1 - 1-3 hours prior

ACTIVE COMPARATOR

Subjects will receive Ultherapy treatment 1-3 hours prior to tissue resection.

Device: Ultherapy Treatment

Group 2 - 1 day prior

ACTIVE COMPARATOR

Subjects will receive Ultherapy treatment 1 day prior to tissue resection.

Device: Ultherapy Treatment

Group 3 - 3 days prior

ACTIVE COMPARATOR

Subjects will receive Ultherapy treatment 3 days prior to tissue resection.

Device: Ultherapy Treatment

Group 4 - 7 days prior

ACTIVE COMPARATOR

Subjects will receive Ultherapy treatment 7 days prior to tissue resection.

Device: Ultherapy Treatment

Group 5 - 45 days prior

ACTIVE COMPARATOR

Subjects will receive Ultherapy treatment 45 days prior to tissue resection.

Device: Ultherapy Treatment

Interventions

Ultherapy Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ulthera System Treatment

Group 1 - 1-3 hours prior; Group 2 - 1 day prior; Group 3 - 3 days prior; Group 4 - 7 days prior; Group 5 - 45 days prior

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 45 to 70 years.
• Subject in good health.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control during the study.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) prior to study treatment and chronic use during the entire post-treatment study period.
• Willingness and ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to performance of any study-related procedure.

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Severe solar elastosis.
• Significant scarring in the area(s) to be treated that would interfere with assessing results.
• Open wounds or lesions in the area(s) to be treated.
• Severe or cystic acne on the area(s) to be treated.
• Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.)
• Inability to understand the protocol or to give informed consent.
• Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
• Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
• BMI equal to or greater than 30.
• History of chronic drug or alcohol abuse.
• History of autoimmune disease.
• Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
• Concurrent enrollment in any study involving the use of investigational devices or drugs.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (2)

North Valley Plastic Surgery

Phoenix, Arizona, 85050, United States

Location

Campbell Facial Plastic Surgery

Mequon, Wisconsin, 53092, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Kari Larson, MBA

  Ulthera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: August 18, 2016
• Study Completion: August 18, 2016
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)