Feasibility Study: Heavy Water Tissue Labeling Protocol
Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility Study: Determination of the Effect of Ultherapy® Treatment on the Rate of Collagen Synthesis in Normal Skin|
- Rate of Collagen Synthesis [ Time Frame: 4 weeks post-treatment ] [ Designated as safety issue: No ]Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.
|Study Start Date:||August 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Ultherapy®-treated tissue
Heavy water labeled tissue receiving an Ulthera® System Treatment
Device: Ulthera® System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy®Other: Heavy Water
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 Name: Deuterated Water
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708525
|United States, California|
|Sasaki Advanced Aesthetic Medical Center|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Gordon Sasaki, MD||Sasaki Advanced Aesthetic Medical Center|