NCT01713985

Brief Summary

Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. 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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 24, 2017

Status Verified

September 1, 2013

Enrollment Period

11 months

First QC Date

October 15, 2012

Last Update Submit

November 21, 2017

Conditions

Skin LaxityWrinkles

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Lifting and Tightening of Skin

    Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.

    180 days post treatment

  • Number of Participants with Wrinkle Reduction

    Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system

    180 days post treatment

Secondary Outcomes (3)

  • Number of Participants with Eyebrow Lift

    90 days post-treatment

  • Number of Participants with Lower face and Neck Lift

    90 days post-treatment

  • Number of Participants Reporting Treatment Satisfaction

    180 days post-treatment

Study Arms (2)

Group A

ACTIVE COMPARATOR

Ulthera System Treatment Right, Thermage Left

Device: Ulthera System TreatmentDevice: Thermage

Group B

ACTIVE COMPARATOR

Ulthera System Treatment Left, Thermage Right

Device: Ulthera System TreatmentDevice: Thermage

Interventions

Ulthera System TreatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ultherapy™
Group AGroup B
ThermageDEVICE

Radiofrequency treatment focusing radiofrequency energy

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Male or female, age 30 to 65 years.
  • Subject in good health.
  • Skin laxity on the area(s) to be treated.
  • 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 area(s) to be treated.
  • Excessive skin laxity on the area(s) to be treated.
  • Significant scarring in the area(s) to be treated.
  • Open wounds or lesions in the area(s) to be treated.
  • Severe or cystic acne on the area(s) to be treated.
  • Presence of a metal stent or implant in the area(s) to be treated.
  • Inability to understand the protocol or to give informed consent.
  • Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
  • Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
  • BMI equal to or greater than 25.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FACES+

San Diego, California, 92121, 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

  • Steven Cohen, MD

    Faces+

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 25, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 24, 2017

Record last verified: 2013-09

Locations

US(1)