Pasadena, California 91105

  • Brachial Ptosis

Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT01713933


Primary Contact:

Principal Investigator
Gordon Sasaki, MD FACS
Sasaki Advanced Aesthetic Medical Center


Backup Contact:

N/A


Location Contact:

Pasadena, California 91105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 13, 2021

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