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Completed

NCT Number: NCT01708252

Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min 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

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DeNova Research

Chicago, Illinois, 60611, United States

About this study

This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction 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 30 to 65 years.
  • Subject in good health.
  • BMI < 30.
  • Skin laxity in the submental area as demonstrated by a grade II or III on the Knize scale for classification of cosmetic deformity of the cervicomental angle
  • Previous participation in ULT-107, and adequate compliance with all treatment and follow-up visits. Groups (surgery or surgery naïve) will be designated based on group assigned in ULT-107).
  • Have not had any concomitant surgical or skin tightening procedures since their Ultherapy™ treatment with ULT-107.

Exclusion criteria

  • Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable form of birth control.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat on the cheeks.
  • Excessive skin laxity on the lower face and neck
  • 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

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 in lower face and neck skin laxity

    Time frame: 90 days post-treatment

    Efficacy will be assessed using the 90-day images compared to baseline

  2. Cervicomental angle

    Time frame: 90 days post-treatment

    Efficacy will be assessed using the 90-day images compared to baseline.

Secondary outcomes

  1. Overall aesthetic improvement

    Time frame: 90 days post-treatment

    Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.

  2. Patient satisfaction

    Time frame: 90 days post-treatment

    Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.

  3. Pain Assessment

    Time frame: Treatment visit

    Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.

  4. Patient Satisfaction

    Time frame: 180 days post-treatment

    Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.

  5. Overall aesthetic improvement

    Time frame: 180 days post-treatment

    Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.

Sponsors and collaborators

Lead sponsor

Ulthera, Inc

Industry

Registry information

Official study title

Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 16, 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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