Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment

NCT01708252 | Completed

• 1 other identifier: ULT-127
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity

Keywords

Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (2)

• Improvement in lower face and neck skin laxity

  Efficacy will be assessed using the 90-day images compared to baseline

  90 days post-treatment

• Cervicomental angle

  Efficacy will be assessed using the 90-day images compared to baseline.

  90 days post-treatment

Secondary Outcomes (5)

• Overall aesthetic improvement

  90 days post-treatment

• Patient satisfaction

  90 days post-treatment

• Pain Assessment

  Treatment visit

• Patient Satisfaction

  180 days post-treatment

• Overall aesthetic improvement

  180 days post-treatment

Study Arms (1)

Ulthera treatment group

EXPERIMENTAL

All subjects will receive an Ulthera System Treatment

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Ulthera treatment group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

DeNova Research

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Steven H Dayan, MD, FACS

  DeNova Research

  PRINCIPAL INVESTIGATOR

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: November 7, 2011
• First Posted: October 16, 2012
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 24, 2017

Record last verified: 2013-06

Locations

US (1)