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Completed

NCT Number: NCT01519934

A Retrospective Study to Evaluate the Effectiveness of the Ulthera System

Up to 120 subjects within the study site's practice who have already had an Ultherapy™ treatment to the face and neck will be enrolled to monitor treatment effectiveness. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained 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 Wrinkles

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Cosmetic Laser Associates

San Diego, California, 92121, United States

About this study

This is a retrospective, single-center clinical trial to evaluate the efficacy of the Ulthera System for non-invasive treatment of skin texture and laxity six months after treatment. Global Aesthetic Improvement Scale scores, patient satisfaction questionnaires, and quality of life questionnaires will 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 25-85 years.
  • Subject in good health.
  • Received Ultherapy™ treatment prior to or on October 1, 2011, and must have had pre-treatment baseline photographs taken.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits.
  • Absence of physical or psychological conditions unacceptable to the investigator.

Exclusion criteria

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Significant scarring in areas treated.
  • Open wounds or lesions in the areas treated.
  • Severe or cystic acne on the areas treated.
  • Inability to understand the protocol or to give informed consent.

Treatment and study plan

Primary outcomes

  1. Improvement in Overall Lifting and Tightening of the Skin

    Time frame: Baseline to 180 days post-treatment

    Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.

Secondary outcomes

  1. Overall Aesthetic Improvement

    Time frame: Baseline to 180 days post-treatment

    Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:

    • = Very Much Improved
    • = Much Improved
    • = Improved
    • = No Change
    • = Worse

  2. Subject Perception of Age

    Time frame: Baseline to 180 days post-treatment

    Percentage of subjects rated as "looking younger" as measured using a Subject Perception of Age questionnaire.

  3. Patient Satisfaction

    Time frame: 180 days post-treatment

    Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Retrospective Evaluation of the Ulthera System for Lifting and Tightening of the Face and Neck

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2012
Registry last updated
Dec 18, 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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