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

Skin Laxity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708252
• Other study ID #: ULT-127
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: November 22, 2017
• Start date: September 2011
• Est. completion date: August 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

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

Locations

Country	Name	City	State
United States	DeNova Research	Chicago	Illinois

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 lower face and neck skin laxity	Efficacy will be assessed using the 90-day images compared to baseline	90 days post-treatment
Primary	Cervicomental angle	Efficacy will be assessed using the 90-day images compared to baseline.	90 days post-treatment
Secondary	Overall aesthetic improvement	Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.	90 days post-treatment
Secondary	Patient satisfaction	Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.	90 days post-treatment
Secondary	Pain Assessment	Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.	Treatment visit
Secondary	Patient Satisfaction	Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.	180 days post-treatment
Secondary	Overall aesthetic improvement	Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.	180 days post-treatment