Feasibility Study: Heavy Water Tissue Labeling Protocol

Completed · Not applicable

Conditions studied: Skin Laxity

In brief

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

Key facts

Study ID

NCT01708525

Run by

Ulthera, Inc

People needed

2

Starts

2012-08-01

Expected to finish

2013-11-01

Last updated by the study team

2017-12-11

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• 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.

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.

Where it is running

• Sasaki Advanced Aesthetic Medical Center — Pasadena, California, United States

Full record on ClinicalTrials.gov

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