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Completed

NCT Number: NCT01485107

Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

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Key information

Conditions

Skin Laxity of the décolleté

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser

San Diego, California, 92121, United States

About this study

This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female, aged 35 to 60 years.
  • Subject in good health.
  • Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
  • 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.
  • Scarring in areas to be treated.
  • Tattoos in the areas to be treated.
  • Patients with ports or defibrillators.
  • Breast size >400cc each as measured by water displacement method.
  • History of breast reduction surgery.
  • Any open wounds or lesions in the area.
  • Active and severe inflammatory acne in the region to be treated.
  • Patients who have a history with keloid formation or hypertropic scarring

Treatment and study plan

Ulthera® System

Device

Focused ultrasound energy delivered below the surface of the skin.

Other names: Ultherapy™ treatment

Primary outcomes

  1. Improvement in overall lifting and tightening of skin

    Time frame: 90 days post-treatment

    Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.

Secondary outcomes

  1. Skin Laxity of the Décolleté

    Time frame: 90 and 180 days post-treatment

    The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline.

  2. Bilateral chest measurements

    Time frame: 90 and 180 days post-treatment

    Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.

  3. Overall aesthetic improvement

    Time frame: 90 and 180 days post-treatment

    Based on Global Aesthetic Improvement Scale (GAIS) scores.

  4. Patient satisfaction

    Time frame: 90 and 180 days post-treatment

    Subject-completed questionnaire.

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 Décolleté

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
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.