CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2 enrolled
Drug / intervention
Ulthera® System Treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01708525
NCT01708525N/ACompleted
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Feasibility Study: Determination of the Effect of Ultherapy® Treatment on the Rate of Collagen Synthesis in Normal Skin

Ulthera, Inc·interventional·Posted Oct 17, 2012·Updated Dec 11, 2017

In Brief

A clinical study evaluating Ulthera® System Treatment and Heavy Water for Skin Laxity. Completed, enrolled 2 participants across 1 site.

Detailed Summary

Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in tissue treated with the Ulthera® System compared to control tissue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Laxity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2012
Enrollment StartAug 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.7 years ago

Interventions

Ulthera® System Treatmentdevice

Focused ultrasound energy delivered below the surface of the skin

Heavy Waterother

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.