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Completed

NCT Number: NCT01708499

Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. 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 Crepiness Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

About this study

This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, 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, aged 25 to 60 years.
  • Subject in good health.
  • Skin laxity in the abdomen
  • 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.

Exclusion criteria

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the abdomen.
  • Excessive skin laxity on the abdomen.
  • Significant scarring in areas to be treated.
  • Open wounds or lesions in the area to be treated.
  • Inability to understand the protocol or to give informed consent.
  • BMI equal to and greater than 30.

Treatment and study plan

Ulthera System Treatment

Device

Focused ultrasound energy delivered below the surface of the skin

Other names: Ultherapy™

Primary outcomes

  1. Improvement laxity/crepiness and texture of abdominal tissue

    Time frame: 90 days post-treatment

    Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline

Secondary outcomes

  1. Overall aesthetic improvement

    Time frame: 180 days post-treatment

    The Global Aesthetic Improvement Scale scores will be obtained from the investigator and subject, comparing post-treatment photos to pre-treatment photos.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue

Important dates

Study start
2012
Primary completion
2013
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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