Feasibility Study: Heavy Water Tissue Labeling Protocol

NCT ID: NCT01708525

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Skin Laxity

Keywords

Ulthera® System; Ultherapy® Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultherapy®-treated tissue

Heavy water labeled tissue receiving an Ulthera® System Treatment

Group Type: EXPERIMENTAL

Ulthera® System Treatment

Intervention Type: DEVICE

Focused ultrasound energy delivered below the surface of the skin

Heavy Water

Intervention Type: OTHER

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.

Interventions

Ulthera® System Treatment

Focused ultrasound energy delivered below the surface of the skin

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Ultherapy®; Deuterated Water

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ulthera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordon Sasaki, MD

Role: PRINCIPAL_INVESTIGATOR

Sasaki Advanced Aesthetic Medical Center

Locations

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, United States

Countries

United States

Other Identifiers

ULT-132

Identifier Type: -

Identifier Source: org_study_id