Clinical trial NCT01708252: Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in lower face and neck skin laxity
timeFrame: 90 days post-treatment
measure: Cervicomental angle
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall aesthetic improvement
timeFrame: 90 days post-treatment
measure: Patient satisfaction
timeFrame: 90 days post-treatment
measure: Pain Assessment
timeFrame: Treatment visit
measure: Patient Satisfaction
timeFrame: 180 days post-treatment
measure: Overall aesthetic improvement
timeFrame: 180 days post-treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H Dayan, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: