Back to resultsFeasibility Study: Heavy Water Tissue Labeling Protocol
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulthera® System Treatment
Heavy Water
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity focused on measuring Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
Eligibility Criteria
Inclusion Criteria:
- Male or female, age 30 to 65 years scheduled for rhytidectomy.
- Subject in good health.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
- Presence of a metal stent or implant in the facial area to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatments to the submental area within two weeks prior to study participation or during the study.
- Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area to be treated.
- BMI equal to or greater than 30.
Sites / Locations
- Sasaki Advanced Aesthetic Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultherapy®-treated tissue
Arm Description
Heavy water labeled tissue receiving an Ulthera® System Treatment
Outcomes
Primary Outcome Measures
Rate of Collagen Synthesis
Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01708525
Brief Title
Feasibility Study: Heavy Water Tissue Labeling Protocol
Official Title
Feasibility Study: Determination of the Effect of Ultherapy® Treatment on the Rate of Collagen Synthesis in Normal Skin
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.
Detailed Description
This study is a prospective, single-center, blinded, non-randomized clinical trial. Two subjects who have chosen to have a surgical facelift procedure and agree to drink heavy water for tissue labeling, will be enrolled. Subjects will consume heavy water and collect saliva specimens over the course of the study period, following a specific heavy water labeling protocol. Two weeks after starting the heavy water protocol, subjects will return to the study site to receive one Ultherapy® treatment to the pre-auricular region on one side of the face. The contra-lateral pre-auricular region will serve as a control. Following Ultherapy® treatment, subjects will continue to follow the heavy water protocol for 4 more weeks. Subjects will then return to the study site to undergo resection of the treated and control tissue for analysis during their planned rhytidectomy procedure. Subjects will send in saliva samples on a weekly basis to allow for confirmation that they are drinking the heavy water.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity
Keywords
Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin tightening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultherapy®-treated tissue
Arm Type
Experimental
Arm Description
Heavy water labeled tissue receiving an Ulthera® System Treatment
Intervention Type
Device
Intervention Name(s)
Ulthera® System Treatment
Other Intervention Name(s)
Ultherapy®
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Intervention Type
Other
Intervention Name(s)
Heavy Water
Other Intervention Name(s)
Deuterated Water
Intervention Description
A tissue labeling model via the consumption of the stable isotope, deuterated water (heavy water). Heavy water consumed over the course of the 6-week study period for a direct kinetic measure of in vivo collagen synthesis. 60 ml (about 12 teaspoons) of heavy water (also called deuterated water or 2H2O), was consumed three times a day for the first five days. Starting on Day 6, two 60 ml doses of heavy water were consumed per day for the remaining 37 days.
Primary Outcome Measure Information:
Title
Rate of Collagen Synthesis
Description
Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
Time Frame
4 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, age 30 to 65 years scheduled for rhytidectomy.
Subject in good health.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control.
Absence of physical or psychological conditions unacceptable to the investigator.
Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Exclusion Criteria:
Presence of an active systemic or local skin disease that may affect wound healing.
Severe solar elastosis.
Significant scarring in areas to be treated.
Open wounds or lesions in the area to be treated.
Severe or cystic acne on the area to be treated.
Presence of a metal stent or implant in the facial area to be treated.
Inability to understand the protocol or to give informed consent.
Microdermabrasion, or prescription level glycolic acid treatments to the submental area within two weeks prior to study participation or during the study.
Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area to be treated.
BMI equal to or greater than 30.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Sasaki, MD
Organizational Affiliation
Sasaki Advanced Aesthetic Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sasaki Advanced Aesthetic Medical Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study: Heavy Water Tissue Labeling Protocol
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