NCT01368965

Brief Summary

This prospective, multi-center, single treatment clinical trial evaluates the clinical outcomes associated with non-invasive treatment to obtain lift and tightening of facial tissue and improve jawline definition in subjects with darker skin color utilizing the Ulthera® System to deliver focused ultrasound energy below the skin surface.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

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, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

June 6, 2011

Results QC Date

February 10, 2014

Last Update Submit

November 16, 2017

Conditions

Facial Skin Laxity

Outcome Measures

Primary Outcomes (1)

  • Change in Overall Lifting and Tightening of Treated Tissue

    The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos

    90 days post treatment

Secondary Outcomes (4)

  • Global Aesthetic Improvement at 90 Days Post-treatment

    90 Days post-treatment

  • Global Aesthetic Improvement at 180 Days Post-treatment

    180 days post-treatment

  • Patient Satisfaction Questionnaire

    90 Days post-treatment

  • Patient Satisfaction Questionnaire

    180 days post-treatment

Other Outcomes (1)

  • Subject Assessment of Pain

    During Ulthera treatment

Study Arms (1)

Ulthera® System treatment

EXPERIMENTAL
Device: Ulthera® System treatment

Interventions

Ulthera® System treatmentDEVICE

Ulthera® System treatment delivering focused ultrasound energy

Ulthera® System treatment

Eligibility Criteria

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

You may qualify if:

  • Male or female, aged 30 to 65 years.
  • Subject in good health.
  • Subjects who desire lift and tightening of cheek tissue, improvement in jawline definition and/or submental skin laxity.
  • Fitzpatrick skin phototypes of 3 through 6.
  • Provide written informed consent and HIPAA authorization

You may not qualify if:

  • Pregnant or lactating.
  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Severe solar elastosis.
  • Excessive subcutaneous fat on the cheek.
  • Excessive skin laxity on the lower face and neck.
  • Significant scarring in areas to be treated.
  • Significant open facial wounds or lesions.
  • Severe or cystic acne on the face.
  • Presence of a metal stent or implant in the facial area to be treated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harris Aesthetics, LLC

Chevy Chase, Maryland, 20815, United States

Location

Dermatology, Cosmetic & Laser Surgery

Rockville, Maryland, 20852, United States

Location

Related Publications (1)

  • Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):355-7. doi: 10.1001/jamafacial.2015.0990.

    PMID: 26313402DERIVED

Limitations and Caveats

Study Limitations: * Masked assessment was not completed as photos were not usable, i.e., poor image quality, positioning and timing. * Site staffing changes. * Overburdened site staff. * Poor photography quality * Subject selection

Results Point of Contact

Title
Public Disclosure Manager
Organization
Merz Pharmaceuticals
clinicaltrials@merz.com

Study Officials

  • Hema Sundaram, M.D.

    Dermatology, Cosmetic & Laser Surgery

    PRINCIPAL INVESTIGATOR

  • Monte O Harris, M.D.

    Harris Aesthetics, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

June 6, 2011

First Posted

June 8, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

August 1, 2012

Last Updated

December 13, 2017

Results First Posted

March 26, 2014

Record last verified: 2017-11

Locations

US(2)