Feasibility Study: Heavy Water Tissue Labeling Protocol

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.