Evaluation of the Ulthera® System for Treatment of the Brachia

NCT01713933 | Completed Results

• 1 other identifier: ULT-114
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Ptosis

Keywords

Ulthera® System; Ultherapy™ treatment; Ulthera, Inc.

Outcome Measures

Primary Outcomes (1)

• Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity

  Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.

  Baseline to 90 days post-treatment

Secondary Outcomes (8)

• Quantitative Improvement in Skin Laxity

  Baseline to 90 days post-treatment

• Change in Dermal Thickness

  Baseline to 90 days post-treatment

• Change in Dermal Thickness

  Baseline to180 days post-treatment

• Overall Aesthetic Improvement

  Baseline to 60 days post-treatment

• Overall Aesthetic Improvement

  Baseline to 90 days post-treatment

Study Arms (1)

Ultherapy™ treatment

EXPERIMENTAL

Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms

Device: Ulthera® System

Interventions

Ulthera® System DEVICE

Focused ultrasound energy delivered below the surface of the skin.

Also known as: Ultherapy™ treatment, Ulthera, Inc., Ultrasound treatment for skin tightening

Ultherapy™ treatment

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

Location

Limitations and Caveats

\- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

Study Officials

• Gordon Sasaki, MD FACS

  Sasaki Advanced Aesthetic Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 25, 2012
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 11, 2017
• Results First Posted: May 26, 2014

Record last verified: 2017-11

Locations

US (1)