NCT01810484

Brief Summary

Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment. Study images will be obtained pre-treatment, approximately 30 minutes 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
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

March 8, 2013

Last Update Submit

January 30, 2018

Conditions

ScarsStriae

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in overall skin texture and appearance of abdominal striae

    A masked, qualitative assessment of change from baseline in the areas treated based a review of 2D images obtained at baseline and 90 days post-treatment.

    90-days post-treatment

Secondary Outcomes (6)

  • 90 Day Patient Satisfaction

    90 Days post-treatment

  • 180 Day Patient Satisfaction

    180 Days post-treatment

  • Change from baseline in overall aesthetic appearance of abdominal striae at 90 days

    90 Days post-treatment

  • Change from baseline in overall aesthetic appearance of abdominal striae at 180 days

    180 Days post-treatment

  • Change from baseline in skin striae texture and depth at 90 Days

    90 Days post-treatment

  • +1 more secondary outcomes

Study Arms (3)

Group 1

ACTIVE COMPARATOR

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment only; Treatment Area B will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area C will be treated with CO2 laser treatment only

Device: Ultherapy® treatment onlyDevice: Ultherapy® treatment and CO2 laser treatmentDevice: CO2 Laser treatment only

Group 2

ACTIVE COMPARATOR

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with Ultherapy® treatment and CO2 laser treatment; Treatment Area B will be treated with CO2 laser treatment only; Treatment Area C will be treated with Ultherapy® treatment only

Device: Ultherapy® treatment onlyDevice: Ultherapy® treatment and CO2 laser treatmentDevice: CO2 Laser treatment only

Group 3

ACTIVE COMPARATOR

The abdominal region will be divided into 3 treatment areas: Treatment Area A, B and C. Treatment Area A will be treated with CO2 laser treatment only; Treatment Area B will be treated with Ultherapy® treatment only; Treatment Area C will be treated with Ultherapy® treatment and CO2 laser treatment

Device: Ultherapy® treatment onlyDevice: Ultherapy® treatment and CO2 laser treatmentDevice: CO2 Laser treatment only

Interventions

Ultherapy® treatment onlyDEVICE

Focused ultrasound energy delivered below the surface of the skin

Also known as: Ulthera® System treatment
Group 1Group 2Group 3
Ultherapy® treatment and CO2 laser treatmentDEVICE

Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin; CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Also known as: Ulthera® System treatment, CO2 Fractional Ablative Laser teatment
Group 1Group 2Group 3
CO2 Laser treatment onlyDEVICE

CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.

Also known as: CO2 Fractional Ablative Laser teatment
Group 1Group 2Group 3

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 21 to 65 years.
  • Subject in good health.
  • Fitzpatrick skin classification type 1-5.
  • Striae rubra and alba on the abdomen.
  • Understands and accepts the obligation not to undergo any other procedures in the area(s) to be treated through the follow-up period.
  • Absence of physical or psychological conditions unacceptable to the investigator.
  • Willingness and ability to provide written consent for study-required photography and adherence to photography requirements .
  • Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
  • Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at Visit 1 and be willing and able to use an acceptable method of birth control during the study

You may not qualify if:

  • Presence of an active systemic or local skin disease that may affect wound healing.
  • Current bacterial or viral infection in the area to be treated.
  • Severe solar elastosis.
  • Significant scarring or burns in area(s) to be treated.
  • Prior radiation therapy in the area(s) to be treated.
  • Open wounds or lesions in the area(s) to be treated.
  • History of keloid or hypertrophic scarring
  • History of irregular pigmentation of the skin, Lichens Planus, Vitiligo or Psoriasis in the treatment area that in the investigators opinion, would put the subject at unnecessary risk.
  • Inability to understand the protocol or to give informed consent.
  • Microdermabrasion, or prescription level glycolic acid treatments to the intended treatment area(s) within two weeks prior to study participation or during the study.
  • History of chronic drug or alcohol abuse.
  • History of autoimmune disease.
  • Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
  • Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  • Subjects who, in the investigator's opinion, have a history of poor cooperation,noncompliance with medical treatment, or unreliability.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Art Plastic Surgery

Paramus, New Jersey, 07652, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 98207, United States

Location

MeSH Terms

Conditions

CicatrixStriae Distensae

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Luis Zapiach, MD

    Art Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 13, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 31, 2018

Record last verified: 2015-01

Locations

US(2)