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Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment

Primary Purpose

Scars, Striae

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultherapy® treatment only
Ultherapy® treatment and CO2 laser treatment
CO2 Laser treatment only
Sponsored by
Ulthera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars focused on measuring Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  • 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

Exclusion Criteria:

  • 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.
  • Concurrent enrollment in any study involving the use of investigational devices or drugs.
  • Current smoker or history of smoking in the last five years.
  • History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty.
  • History of prior Massive Weight Loss
  • History of using the following prescription medications:

    1. Accutane or other systemic retinoids within the past 12 months;
    2. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);
    3. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.

Sites / Locations

  • Art Plastic Surgery
  • Dermatology, Laser & Vein Specialists of the Carolinas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

90 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
180 Day Patient Satisfaction
Based on completion of Patient Satisfaction Questionnaires
Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area
Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area
Change from baseline in skin striae texture and depth at 90 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment.
Change from baseline in skin striae texture and depth at 180 Days
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment.

Full Information

First Posted
March 8, 2013
Last Updated
January 30, 2018
Sponsor
Ulthera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01810484
Brief Title
Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment
Official Title
Feasibility Study: Evaluation of the Ulthera® System in Combination With 70W Alma Pixel CO2 Fractional Ablative Laser for Improvement of Abdominal Striae
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ulthera, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, randomized, single-blinded, pilot clinical trial to evaluate the use of the Ulthera® System in combination with the 70W Alma Pixel CO2 laser for efficacious results in the treatment of abdominal striae rubra and striae alba. Subjects will be randomized to one of three treatment groups. Study personnel conducting efficacy measures will be blinded to the assigned treatment groups. Changes from baseline in overall skin texture and appearance of abdominal striae will be assessed at study follow-up visits. 2D images, 3D images and patient satisfaction questionnaires will be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars, Striae
Keywords
Ulthera® System, Ultherapy® Treatment, Ulthera, Inc., Ultrasound treatment for skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ultherapy® treatment only
Other Intervention Name(s)
Ulthera® System treatment
Intervention Description
Focused ultrasound energy delivered below the surface of the skin
Intervention Type
Device
Intervention Name(s)
Ultherapy® treatment and CO2 laser treatment
Other Intervention Name(s)
Ulthera® System treatment, CO2 Fractional Ablative Laser teatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CO2 Laser treatment only
Other Intervention Name(s)
CO2 Fractional Ablative Laser teatment
Intervention Description
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Primary Outcome Measure Information:
Title
Change from baseline in overall skin texture and appearance of abdominal striae
Description
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.
Time Frame
90-days post-treatment
Secondary Outcome Measure Information:
Title
90 Day Patient Satisfaction
Description
Based on completion of Patient Satisfaction Questionnaires
Time Frame
90 Days post-treatment
Title
180 Day Patient Satisfaction
Description
Based on completion of Patient Satisfaction Questionnaires
Time Frame
180 Days post-treatment
Title
Change from baseline in overall aesthetic appearance of abdominal striae at 90 days
Description
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 90 days post-treatment based on review of pretreatment and 90 day post-treatment 2D images and a live assessment of the treatment area
Time Frame
90 Days post-treatment
Title
Change from baseline in overall aesthetic appearance of abdominal striae at 180 days
Description
Assessment of change in overall aesthetic appearance of abdominal striae from baseline to 180 days post-treatment based on review of pretreatment and 180 day post-treatment 2D images and a live assessment of the treatment area
Time Frame
180 Days post-treatment
Title
Change from baseline in skin striae texture and depth at 90 Days
Description
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 90 days post-treatment.
Time Frame
90 Days post-treatment
Title
Change from baseline in skin striae texture and depth at 180 Days
Description
Quantitative analysis will be completed comparing 3D images obtained at baseline to 3D images obtained at 180 days post-treatment.
Time Frame
180 Days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. 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 Exclusion Criteria: 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. Concurrent enrollment in any study involving the use of investigational devices or drugs. Current smoker or history of smoking in the last five years. History of prior abdominal Suction Assisted Lipectomy or Abdominoplasty. History of prior Massive Weight Loss History of using the following prescription medications: Accutane or other systemic retinoids within the past 12 months; Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix); Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Zapiach, MD
Organizational Affiliation
Art Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Art Plastic Surgery
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Dermatology, Laser & Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
98207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment

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