Feasibility Study: Histological Characterization After Treatment With the Ulthera® System

Skin Laxity Clinical Trial

Official title:

Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01713569
• Other study ID #: ULT-122
• Status: Terminated
• Phase: N/A
• First received: October 22, 2012
• Last updated: November 22, 2017
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48 hours post-treatment, on the day of their rhytidectomy. Study images will be obtained pretreatment, immediately post-treatment, and at the follow-up visit.

Description:

This study is a prospective, single-center clinical trial. Subjects will be enrolled at the investigator's discretion if they meet inclusion/ exclusion criteria and provide written informed consent. Enrolled subjects will be treated with an assigned transducer based on their order of enrollment. At the study follow-up visit, subjects will undergo resection of the treated tissue for histological analysis prior to their planned rhytidectomy procedure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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 (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: a) Postmenopausal for at least 12 months prior to study; b) Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six months prior to study enrollment.

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Ulthera Treatment
Focused ultrasound energy delivered below the surface of the skin

Locations

Country	Name	City	State
United States	Sasaki Advanced Aesthetic Medical Center	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the depth of focused thermal injury and thermal injury zone dimensions.	Post-treatment, treated tissue will be resected for histological analysis.	48 hours post-treatment