Feasibility Study: Heavy Water Tissue Labeling Protocol

NCT01708525 | Completed Results

• 1 other identifier: ULT-132
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of Collagen Synthesis

  Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.

  4 weeks post-treatment

Study Arms (1)

Ultherapy®-treated tissue

EXPERIMENTAL

Heavy water labeled tissue receiving an Ulthera® System Treatment

Device: Ulthera® System Treatment; Other: Heavy Water

Interventions

Ulthera® System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy®

Ultherapy®-treated tissue

Heavy Water 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.

Also known as: Deuterated Water

Ultherapy®-treated tissue

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Interventions

Deuterium Oxide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Deuterium; Hydrogen; Elements; Gases

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.

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Gordon Sasaki, MD

  Sasaki Advanced Aesthetic Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2017
• Results First Posted: December 12, 2014

Record last verified: 2017-11

Locations

US (1)