NCT01708499

Brief Summary

Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
8 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 24, 2017

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

October 15, 2012

Last Update Submit

November 21, 2017

Conditions

Skin LaxitySkin Crepiness

Keywords

Ulthera® SystemUltherapy™ TreatmentUlthera, Inc.Ultrasound treatment for skin tightening

Outcome Measures

Primary Outcomes (1)

  • Improvement laxity/crepiness and texture of abdominal tissue

    Determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline

    90 days post-treatment

Secondary Outcomes (1)

  • Overall aesthetic improvement

    180 days post-treatment

Study Arms (1)

Study treatment

EXPERIMENTAL

All enrolled subjects will receive one Ulthera System Treatment.

Device: Ulthera System Treatment

Interventions

Ulthera System TreatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™
Study treatment

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, aged 25 to 60 years.
  • Subject in good health.
  • Skin laxity in the abdomen
  • 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.
  • Severe solar elastosis.
  • Excessive subcutaneous fat in the abdomen.
  • Excessive skin laxity on the abdomen.
  • Significant scarring in areas to be treated.
  • Open wounds or lesions in the area to be treated.
  • Inability to understand the protocol or to give informed consent.
  • BMI equal to and greater than 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sasaki Advanced Aesthetic Medical Center

Pasadena, California, 91105, United States

Location

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

  • Gordon Sasaki, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
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

March 1, 2012

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

November 24, 2017

Record last verified: 2013-06

Locations

US(1)