Chicago, Illinois 60611

  • Skin Laxity

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT01708252


Primary Contact:

Principal Investigator
Steven H Dayan, MD, FACS
DeNova Research


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60611
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 12, 2021

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