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OpenTrials
Completed

NCT Number: NCT01708382

Feasibility Study: Lifting and Tightening of the Elbows

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.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Cosmetic, Skin and Laser Surgery Center

New York, 10065, United States

About this study

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve skin laxity above the elbows. Masked assessment of pre- and post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ulthera System Treatment

Device

Focused ultrasound energy delivered below the surface of the skin

Other names: Ultherapy™

Primary outcomes

  1. Overall improvement of skin laxity in the areas treated

    Time frame: 90 days post-treatment

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

Secondary outcomes

  1. Aesthetic improvement

    Time frame: 90 and 180 days post-treatment

    GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - A Feasibility Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 17, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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