NCT01422538

Brief Summary

This clinical trial will evaluate clinical outcomes associated with the non-invasive Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® 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 May 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

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 27, 2013

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

August 22, 2011

Results QC Date

June 19, 2013

Last Update Submit

November 16, 2017

Conditions

Skin Laxity

Keywords

Ulthera® SystemUltherapy™ treatmentUlthera, Inc.Ultrasound treatment for skin tighteningSkin laxity on the face and neck.

Outcome Measures

Primary Outcomes (1)

  • Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.

    Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.

    90 days post-treatment

Secondary Outcomes (4)

  • Overall Aesthetic Improvement at 90 Days Post-treatment

    90 days post-treatment.

  • Overall Aesthetic Improvement at 180 Days Post-treatment

    180 days post-treatment

  • Subject Satisfaction at 90 Days Post-treatment

    90 days post-treatment.

  • Subject Satisfaction at 180 Days Post-treatment

    180 days post-treatment

Other Outcomes (1)

  • Subject's Assessment of Pain

    During Ulthera study treatment

Study Arms (3)

Group A

ACTIVE COMPARATOR

Subjects will receive Ulthera® System alone.

Device: Ulthera® System

Group B

ACTIVE COMPARATOR

Sculptra® only

Drug: Sculptra®

Group C

ACTIVE COMPARATOR

Sculptra® treatment followed by Ultherapy™ treatment

Other: Sculptra® treatment followed by Ultherapy™ treatment

Interventions

Ulthera® SystemDEVICE

Focused ultrasound energy delivered below the surface of the skin on the lower face.

Also known as: Ultherapy™
Group A
Sculptra®DRUG

Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.

Also known as: Poly-L-Lactic acid fillers
Group B
Sculptra® treatment followed by Ultherapy™ treatmentOTHER

Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.

Group C

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, aged 35 to 60 years.
  • Subject in good health.
  • Skin laxity in the lower face and neck.
  • Grade 1 and 2 on the Knize Scale

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 face and neck.
  • Excessive skin laxity on the face and neck.
  • No scarring in areas to be treated.
  • Any open facial wounds or lesions.
  • Acne on the face.
  • Patients who have a history with keloid formation or hypertropic scarring
  • Patients who have a hypersensitivity to injectable poly-L-lactic acid
  • 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 (1)

EpiCentre Park Lane

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Interventions

New-Fill

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

* Entrance criteria possibly restricted to a population with too little skin laxity to assess a difference. * Group C time from Sculptra to Ultherapy may be too long to discern any added benefit of both treatments.

Results Point of Contact

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

Study Officials

  • Jay Burns, MD

    EpiCentre Park Lane

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 24, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

December 13, 2017

Results First Posted

August 27, 2013

Record last verified: 2017-11

Locations

US(1)