Feasibility Study: Heavy Water Tissue Labeling Protocol

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.

• Ulthera® System Treatment (Device), also known as Ultherapy®: Focused ultrasound energy delivered below the surface of the skin
• Heavy Water (Other), also known as Deuterated 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.

Primary outcomes

• Rate of Collagen Synthesis [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.

Sex: All, ages: 30 Years to 65 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• Rate of Collagen Synthesis (Primary), Number, percentage of new collagen synthesized: Untreated Tissue 15.71; Ultherapy®-Treated Tissue 21.22

Adverse events

Time frame: Adverse events were collected from baseline through tissue resection, i.e., 4 weeks post-Ultherapy® treatment.

Limitations and caveats: A limitation of this trial includes only a two subject study population due to the extremely high expense of the tissue analyses conducted. High expense precluded further research in a randomized designed trial with a broader patient population.

• Gordon Sasaki, MD, Principal investigator, Sasaki Advanced Aesthetic Medical Center