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

NCT01883414 | Terminated

• 1 other identifier: ULT-136 Avram
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Scar

Keywords

Ulthera, Ultherapy, Surgical scar, scar,

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (3)

• 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.

  90 Days

• 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.

  90 Days

• 3. Patient satisfaction questionnaire at the 90-day follow-up visit.

  90 Days

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Device: Ultherapy™

Group B

ACTIVE COMPARATOR

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

Device: Ultherapy™

Interventions

Ultherapy™ DEVICE

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulthera, Inc: lead

Study Sites (1)

MGH Dermatology Laser and Cosmetic Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathew Avram, MD

  MGH Dermatology, Laser and Cosmetic Center

  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: June 18, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 24, 2017

Record last verified: 2014-03

Locations

US (1)