Clinical trial NCT01713933: Evaluation of the Ulthera® System for Treatment of the Brachia
Official title: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Ptosis
Keywords: Ulthera® System
Ultherapy™ treatment
Ulthera, Inc.
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.

Detailed description: This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study photographs of the upper arms will be taken prior to treatment, immediately post-treatment, and at each follow-up visit. Brachial volume and dermal thickness measurements will be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 19 - 55 years.
* Subject in good health.
* Subjects who desire lift and tightening of the brachia and improvement in skin laxity.
* Mild to moderate laxity of the upper arm.
* Mild to moderate subcutaneous fat of the upper arm.
* Mild crepiness of the skin of the upper arm.
* 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.
* Severe solar elastosis.
* Excessive subcutaneous fat in the upper arm.
* Excessive skin laxity in the upper arm.
* Significant scarring in areas to be treated.
* Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in the treatment areas.

Primary outcomes:
measure: Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
timeFrame: Baseline to 90 days post-treatment
Secondary outcomes:
measure: Quantitative Improvement in Skin Laxity
timeFrame: Baseline to 90 days post-treatment
measure: Change in Dermal Thickness
timeFrame: Baseline to 90 days post-treatment
measure: Change in Dermal Thickness
timeFrame: Baseline to180 days post-treatment
measure: Overall Aesthetic Improvement
timeFrame: Baseline to 60 days post-treatment
measure: Overall Aesthetic Improvement
timeFrame: Baseline to 90 days post-treatment
measure: Overall Aesthetic Improvement
timeFrame: Baseline to180 days post-treatment
measure: Patient Satisfaction
timeFrame: Baseline to 90 days post-treatment
measure: Patient Satisfaction
timeFrame: Baseline to 180 days post-treatment
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Sasaki Advanced Aesthetic Medical Center
state: California
Study officials:
affiliation: Sasaki Advanced Aesthetic Medical Center
name: Gordon Sasaki, MD FACS
role: PRINCIPAL_INVESTIGATOR
References: