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Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.

Primary Purpose

Surgical Scar

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultherapy™
Sponsored by
Ulthera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Scar focused on measuring Ulthera, Ultherapy, Surgical scar, scar,

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female, age 18 to 70 years.
  2. Subject in good health.
  3. Subjects will have regularly shaped surgical scars on the chest, abdomen or back that are at least 4 cm long, are no wider than 1 cm, and are at least 6 months old.
  4. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
  5. 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.
  6. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:

    • Postmenopausal for at least 12 months prior to study;
    • Without a uterus and/or both ovaries; or
    • Bilateral tubal ligation at least six months prior to study enrollment.

Exclusion Criteria:

  1. Presence of an active systemic or local skin disease that may affect wound healing.
  2. Allergy to any pain medications used in the study (lidocaine, NSAIDs, narcotics, etc.)
  3. Severe solar elastosis.
  4. Open wounds or lesions in the area(s) to be treated.
  5. Severe or cystic acne on the area(s) to be treated.
  6. Presence of a metal stent or implant in the area(s) to be treated.
  7. Inability to understand the protocol or to give informed consent.
  8. Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within three months prior to study participation or during the study.
  9. Intralesional kenalog in the past 6 months.
  10. History of chronic drug or alcohol abuse.
  11. History of autoimmune disease.
  12. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
  13. Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  14. Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
  15. Concurrent enrollment in any study involving the use of investigational devices or drugs.
  16. Current smoker or history of smoking in the last year.
  17. History of the following treatments in the area(s) to be treated:

    1. Skin tightening procedure within the past year;
    2. Injectable filler of any type within the past:

    i. 12 months for Hyaluronic acid fillers (e.g. Restylane) ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse) iii. 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra) iv. Ever for permanent fillers (e.g. Silicone, ArteFill) c. Neurotoxins within the past three months; d. Ablative resurfacing laser treatment; e. Nonablative, rejuvenative laser or light treatment within the past six months; f. Surgical dermabrasion or deep peels; g. Any history of contour threads.

  18. History of using the following prescription medications:

    1. Accutane or other systemic retinoids within the past six months;
    2. Topical Retinoids within the past two weeks;
    3. Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, etc.);
    4. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
    5. Subjects that are immunocompromised or are on immunosuppressive therapy
  19. Subjects that are immunocompromised or are on immunosuppressive therapy
  20. History of keloids

Sites / Locations

  • MGH Dermatology Laser and Cosmetic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Subjects randomized to Group A will receive Ultherapy™ treatment on the superior or lateral half of the scar.

Subjects randomized to Group B will receive Ultherapy™ treatment on the inferior or medial half of the scar.

Outcomes

Primary Outcome Measures

The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.
Masked assessors will compare baseline images to images obtained at the 90 day follow up time point in a blinded fashion.

Secondary Outcome Measures

1. Improvement in POSAS score of the treated half of the scar as assessed by the observer using the Patient and Observer Scar Assessment Scale (POSAS) at 90-days post-treatment compared to baseline.
The observer will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
2. Difference in POSAS score as assessed by the patient using the Patient Observer Scar Assessment Scale (POSAS) between the treated and untreated half of the scar at 90-days post-treatment compared to baseline.
The subject will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
3. Patient satisfaction questionnaire at the 90-day follow-up visit.
Each subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 90 follow-up visit. These results will be tabulated to assess subjects satisfaction with the treatment.

Full Information

First Posted
June 18, 2013
Last Updated
November 22, 2017
Sponsor
Ulthera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01883414
Brief Title
Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.
Official Title
Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of resources to manage trial; lack of efficacy.
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (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 25 subjects will be enrolled. Enrolled subjects will received on Ulthera® treatment on one half of their surgical scar. Follow up visits will occur at 30, 90 and 180 days after treatment. Study images will be obtained before treatment, immediately after treatment and at each follow-up visit.
Detailed Description
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® system to improve the appearance of scar tissue on the neck, abdomen or back. Changes from baseline of the Patient Observer Scar Assessment Scale score will be assessed at study follow-up visits. Images will be obtained prior to treatment and at each follow up visit. Patient satisfaction questionnaires will also be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Scar
Keywords
Ulthera, Ultherapy, Surgical scar, scar,

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 A
Arm Type
Active Comparator
Arm Description
Subjects randomized to Group A will receive Ultherapy™ treatment on the superior or lateral half of the scar.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects randomized to Group B will receive Ultherapy™ treatment on the inferior or medial half of the scar.
Intervention Type
Device
Intervention Name(s)
Ultherapy™
Intervention Description
All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area.
Primary Outcome Measure Information:
Title
The primary endpoint is improvement in appearance of scar tissue as determined by a masked, qualitative assessment of photographs at 90-days post-treatment time points comparing the treated to untreated side of the scar.
Description
Masked assessors will compare baseline images to images obtained at the 90 day follow up time point in a blinded fashion.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
1. Improvement in POSAS score of the treated half of the scar as assessed by the observer using the Patient and Observer Scar Assessment Scale (POSAS) at 90-days post-treatment compared to baseline.
Description
The observer will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Time Frame
90 Days
Title
2. Difference in POSAS score as assessed by the patient using the Patient Observer Scar Assessment Scale (POSAS) between the treated and untreated half of the scar at 90-days post-treatment compared to baseline.
Description
The subject will complete the Patient and Observer Scar Assessment Scale (6 questions) prior to treatment and at each follow up visit on both halves of the scar (treated and untreated). Scores will be tabulated and compared for improvement at 90 days after treatment.
Time Frame
90 Days
Title
3. Patient satisfaction questionnaire at the 90-day follow-up visit.
Description
Each subject will complete a Patient Satisfaction Questionnaire (PSQ) at the 90 follow-up visit. These results will be tabulated to assess subjects satisfaction with the treatment.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, age 18 to 70 years. Subject in good health. Subjects will have regularly shaped surgical scars on the chest, abdomen or back that are at least 4 cm long, are no wider than 1 cm, and are at least 6 months old. Understands and accepts the obligation not to undergo any other procedures in the areas 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. Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history: Postmenopausal for at least 12 months prior to study; Without a uterus and/or both ovaries; or Bilateral tubal ligation at least six months prior to study enrollment. Exclusion Criteria: Presence of an active systemic or local skin disease that may affect wound healing. Allergy to any pain medications used in the study (lidocaine, NSAIDs, narcotics, etc.) Severe solar elastosis. 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 three months prior to study participation or during the study. Intralesional kenalog in the past 6 months. 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 year. History of the following treatments in the area(s) to be treated: Skin tightening procedure within the past year; Injectable filler of any type within the past: i. 12 months for Hyaluronic acid fillers (e.g. Restylane) ii. 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse) iii. 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra) iv. Ever for permanent fillers (e.g. Silicone, ArteFill) c. Neurotoxins within the past three months; d. Ablative resurfacing laser treatment; e. Nonablative, rejuvenative laser or light treatment within the past six months; f. Surgical dermabrasion or deep peels; g. Any history of contour threads. History of using the following prescription medications: Accutane or other systemic retinoids within the past six months; Topical Retinoids within the past two weeks; Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, etc.); Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent. Subjects that are immunocompromised or are on immunosuppressive therapy Subjects that are immunocompromised or are on immunosuppressive therapy History of keloids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew Avram, MD
Organizational Affiliation
MGH Dermatology, Laser and Cosmetic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH Dermatology Laser and Cosmetic Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study: Evaluation of the Ulthera® System for Improvement of Surgical Scars.

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