Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.

Detailed Description
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Study subjects will be assigned to one of two treatment groups. Both treatment groups will receive treatment in the center of the forehead/temples, medial cheeks, and chin regions using the 1.5mm and 1.0mm transducers. For Group A, both the 1.5mm and 1.0mm transducers will be used at 0.25J energy setting and 0.20J energy setting, respectively. For Group B, both the 1.5mm and 1.0mm transducers will be used at 0.18J energy setting and 0.15J energy setting, respectively. Subjects will receive 3 Ultherapy treatments administered 2 weeks apart. Subjects will be required to return for follow-up assessments at 14, 30, 60, 90 and 180 days following the third Ultherapy treatment. Pre- and post-treatment photos will be taken. In addition, pre- and post-treatment lesion counts and sebum measurements will be obtained.

Official Title
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Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne

Conditions
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Facial Acne

Intervention / Treatment
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* Device: Ulthera System Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 years and older. Subject in good health. Presence of clinically-evident facial acne of moderate to severe severity with at least 20 inflammatory lesions and 20-100 noninflammatory lesions. Exclusion Criteria: Presence of >2 nodular lesions in the areas to be treated. Presence of any cysts in the areas to be treated. Presence of an active systemic or local skin disease that may affect wound healing. Use of alcohol-based topical solutions or exfoliating agents within 1 week prior to study participation. History of frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections. History of keloid scar formation. Significant scarring in areas to be treated. Significant open facial wounds or lesions. Presence of a metal stent or implant in the facial area to be treated.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively. | Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ulthera, Inc.;|
| Active Comparator: Group B<br>Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively. | Device: Ulthera System Treatment<br>* Focused ultrasound energy delivered below the surface of the skin.<br>* Other names: Ulthera, Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in facial acne | Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline. | 60 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in skin clarity | Measured using a digital imaging system comparing baseline and post-treatment images. | 180 days post-treatment | 
| Reduction of sebum production | Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments. | 180 days post-treatment | 
| Patient Satisfaction at 60 days | Patient satisfaction as determined by completion of a patient satisfaction questionnaire. | 60 day post-treatment | 
| Patient Satisfaction at 180 days | Patient satisfaction as determined by completion of patient satisfaction questionnaire. | 180 Days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.