Evaluation of the Ulthera System for the Treatment of the Decolletage

Not Applicable

Completed

Conditions: Chest Wrinkles

Interventions: Device: Ulthera System Treatment

Registration Number: NCT01713686

Lead Sponsor: Ulthera, Inc

Brief Summary: This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 129

Inclusion Criteria

Female, aged 35 to 70 years.
Subject in good health.
Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
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.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.
Absence of physical conditions unacceptable to the investigator.
Willingness and ability to provide written consent for study-required photography.
Willingness and ability to provide written informed consent.

Exclusion Criteria

Presence of an active systemic or local skin disease that may affect wound healing.
Scarring in areas to be treated.
Tattoos in the areas to be treated.
Patients with ports or defibrillators.
Any open wounds or lesions in the area.
Active and severe inflammatory acne in the region to be treated.
Patients who have a history with keloid formation or hypertrophic scarring.
Inability to understand the protocol or to give informed consent.
Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
History of chronic drug or alcohol abuse.
History of autoimmune disease.
Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
Subjects who anticipate the need for surgery or overnight hospitalization during the study.
Subjects who 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 one year.
History of using the following prescription medications:
1. Topical Retinoids to the area within the past two weeks;
2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulthera System Treatment	Ulthera System Treatment	A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment	90 Days post-treatment	Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment	180 days post treatment	Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline. "Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo. "Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.

Secondary Outcome Measures

Name	Time	Method
Overall Aesthetic Improvement at 180 Days Post-treatment	180 days post-treatment	The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved
Subject Satisfaction at 180 Days Post-treatment	180 days post-treatment	Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied
Subject Satisfaction at 90 Days Post-treatment	90 days post-treatment	Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors: 1. Very Satisfied 2. Satisfied 3. Neither Satisfied or Dissatisfied 4. Dissatisfied 5. Very Dissatisfied "Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied
Overall Aesthetic Improvement at 90 Days Post-treatment	90 days post-treatment	The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors: 1. Very much improved 2. Much improved 3. Improved 4. No change 5. Worse The scale was completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and * Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs. "Improved" = Very Much Improved + Much Improved + Improved

Trial Locations

Locations (4): Laser Skin and Surgery Center of Northern California
🇺🇸
Sacramento, California, United States
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
🇺🇸
San Diego, California, United States
Denova Research
🇺🇸
Chicago, Illinois, United States
Tennessee Research Center
🇺🇸
Nashville, Tennessee, United States