Feasibility Study: Lifting and Tightening Neck Skin in Patients

NCT01708928 | Completed

• 1 other identifier: ULT-107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the lower two thirds of the face and neck. Subjects will be equally grouped into those with a history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment. Study images will be obtained pre-treatment, 30-60 minutes 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 (1)

• Change in submental volume

  Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.

  90 days post-treatment

Secondary Outcomes (1)

• Overall improvement of the submental area

  90 days post-treatment

Study Arms (2)

Group A

ACTIVE COMPARATOR

Subjects who have previous history of submentoplasty and or rhytidectomy

Device: Ulthera System Treatment

Group B

ACTIVE COMPARATOR

Subjects naïve to submentoplasty and or rhytidectomy

Device: Ulthera System Treatment

Interventions

Ulthera System Treatment DEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™

Group A; Group B

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, aged 30 to 65 years
• Subject in good health
• Body Mass index of less than 30
• Present with unwanted skin laxity in the submental area as demonstrated by a grade 2 or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental angle
• Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months previous to enrollment and not to exceed 120 months prior to enrollment
• Understands and accepts the obligation not to receive any other procedures in the submental areas thru the 6 month follow up visit
• Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control

You may not qualify if:

• Pregnant, lactating or planning to become pregnant and or not using a reliable form of birth control
• Has an active systemic or local skin disease that may alter wound healing
• Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy within the last 12 months or greater than 120 months
• Subjects with a prior cosmetic or medical history of submentoplasty and or Rhytidectomy

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 Dayan, MD

  DeNova Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 24, 2017

Record last verified: 2013-06

Locations

US (1)