Feasibility Study: Lifting and Tightening of the Elbows

NCT01708382 | Completed

• 1 other identifier: ULT-108
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Conditions

Skin Laxity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall improvement of skin laxity in the areas treated

  Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.

  90 days post-treatment

Secondary Outcomes (1)

• Aesthetic improvement

  90 and 180 days post-treatment

Study Arms (1)

Ultherapy treatment on the elbows

EXPERIMENTAL

All enrolled subjects will receive one Ultherapy treatment to the elbows.

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Ultherapy treatment on the elbows

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 21 to 65 years.
• Subject in good health.
• Mild to moderate skin laxity on the elbows.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• 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

You may not qualify if:

• Presence of an active systemic or local skin disease that may affect wound healing.
• Excessive subcutaneous fat around the elbows.
• Excessive skin laxity around the elbows.
• Significant scarring in areas to be treated.
• Significant open wounds or lesions in the area to be treated

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

New York Cosmetic, Skin and Laser Surgery Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Cutis Laxa

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

Study Officials

• Cameron K Rokhsar, MD

  New York Cosmetic, Skin, and Laser Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• 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: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 24, 2017

Record last verified: 2013-06

Locations

US (1)