Feasibility Study: Heavy Water Tissue Labeling Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708525
Recruitment Status : Completed
First Posted : October 17, 2012
Results First Posted : December 12, 2014
Last Update Posted : December 11, 2017
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

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.

Condition or disease Intervention/treatment Phase
Skin Laxity Device: Ulthera® System Treatment Other: Heavy Water Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : August 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708525

United States, California
Sasaki Advanced Aesthetic Medical Center
Pasadena, California, United States, 91105
Sponsors and Collaborators
Ulthera, Inc
Principal Investigator: Gordon Sasaki, MD Sasaki Advanced Aesthetic Medical Center

Responsible Party: Ulthera, Inc Identifier: NCT01708525     History of Changes
Other Study ID Numbers: ULT-132
First Posted: October 17, 2012    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: December 11, 2017
Last Verified: November 2017

Keywords provided by Merz North America, Inc. ( Ulthera, Inc ):
Ulthera® System
Ultherapy® Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening

Additional relevant MeSH terms:
Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases
Deuterium Oxide
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs