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

Skin Laxity of the décolleté Clinical Trial

Official title:

Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Décolleté

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485107
• Other study ID #: ULT-105
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: November 22, 2017
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity of the décolleté

Intervention

Device:
• Ulthera® System
Focused ultrasound energy delivered below the surface of the skin.

Locations

Country	Name	City	State
United States	Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in overall lifting and tightening of skin	Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline.	90 days post-treatment
Secondary	Skin Laxity of the Décolleté	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.	90 and 180 days post-treatment
Secondary	Bilateral chest measurements	Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin.	90 and 180 days post-treatment
Secondary	Overall aesthetic improvement	Based on Global Aesthetic Improvement Scale (GAIS) scores.	90 and 180 days post-treatment
Secondary	Patient satisfaction	Subject-completed questionnaire.	90 and 180 days post-treatment