Feasibility Study: Heavy Water Tissue Labeling Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01708525
First received: October 15, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Skin Laxity
Device: Ulthera System Treatment
Other: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Rate of collagen synthesis [ Time Frame: 4 weeks post-treatment ] [ Designated as safety issue: No ]
    Resected tissues will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy™ compared to non-treated tissue.


Enrollment: 2
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ulthera treated tissue
Heavy water label tissue receiving an Ulthera System Treatment
Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin
Other Name: Ultherapy™
Active Comparator: Non-Ulthera treated tissue
Heavy water labeled tissue serving as a control, i.e., no Ulthera System Treatment
Other: Control
No Ulthera System 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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708525

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

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01708525     History of Changes
Other Study ID Numbers: ULT-132
Study First Received: October 15, 2012
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 24, 2014