NCT01708434

Brief Summary

Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
Last Updated

November 24, 2017

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

October 15, 2012

Last Update Submit

November 21, 2017

Conditions

Skin Laxity

Keywords

Skin laxityKnees

Outcome Measures

Primary Outcomes (1)

  • Improvement in overall lifting and tightening of knee skin laxity.

    Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale.

    90 and 180 days post-treatment

Secondary Outcomes (1)

  • Overall improvement in skin laxity.

    90 and 180 days post-treatment

Study Arms (1)

Ulthera® treatment of the knees

EXPERIMENTAL

Bilateral treatment of the knees using the Ulthera® System

Device: Ulthera® System

Interventions

Ulthera® SystemDEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™ treatment
Ulthera® treatment of the knees

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, aged 30 to 65 years.
  • Subject in good health.
  • Mild to moderate skin laxity around the knees.
  • 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.
  • Excessive subcutaneous fat around the knees.
  • Excessive skin laxity around the knees.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Related Publications (1)

  • Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). J Cosmet Laser Ther. 2014 Oct;16(5):225-9. doi: 10.3109/14764172.2014.949273. Epub 2014 Sep 2.

    PMID: 25065380DERIVED

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Michael Gold, MD

    Tennessee Clinical Research Center

    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

October 15, 2012

First Posted

October 17, 2012

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

November 24, 2017

Record last verified: 2013-06

Locations

US(1)