Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
NCT ID: NCT01591304
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2011-08-31
2014-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Group B
Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.
Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Interventions
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Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Ulthera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Girish Munavalli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dermatology, Laser & Vein Specialists of the Carolinas
Locations
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Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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ULT-116
Identifier Type: -
Identifier Source: org_study_id