- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713686
Evaluation of the Ulthera System for the Treatment of the Decolletage
Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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Sacramento, California, United States, 95816
- Laser Skin and Surgery Center of Northern California
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San Diego, California, United States, 92121
- Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
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-
Illinois
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Chicago, Illinois, United States, 60611
- DeNova Research
-
-
Tennessee
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Nashville, Tennessee, United States, 37215
- Tennessee Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Topical Retinoids to the area within the past two weeks;
- Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
- Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ulthera System Treatment
A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
|
Focused ultrasound energy delivered below the surface of the skin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
Time Frame: 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. |
90 Days post-treatment
|
Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
Time Frame: 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. |
180 days post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Aesthetic Improvement at 90 Days Post-treatment
Time Frame: 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:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved |
90 days post-treatment
|
Overall Aesthetic Improvement at 180 Days Post-treatment
Time Frame: 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:
The scale was completed in two steps:
"Improved" = Very Much Improved + Much Improved + Improved |
180 days post-treatment
|
Subject Satisfaction at 90 Days Post-treatment
Time Frame: 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:
"Satisfied"= Very Satisfied + Satisfied "Dissatisfied"=Dissatisfied + Very Dissatisfied |
90 days post-treatment
|
Subject Satisfaction at 180 Days Post-treatment
Time Frame: 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:
"Satisfied" = Very Satisfied + Satisfied "Dissatisfied" = Dissatisfied + Very Dissatisfied |
180 days post-treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ULT-129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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