- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708525
Feasibility Study: Heavy Water Tissue Labeling Protocol
November 10, 2017 updated by: Ulthera, Inc
Feasibility Study: Determination of the Effect of Ultherapy® Treatment on the Rate of Collagen Synthesis in Normal Skin
Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Sasaki Advanced Aesthetic Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultherapy®-treated tissue
Heavy water labeled tissue receiving an Ulthera® System Treatment
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Collagen Synthesis
Time Frame: 4 weeks post-treatment
|
Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
|
4 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
October 15, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 17, 2012
Study Record Updates
Last Update Posted (Actual)
December 11, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULT-132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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