Facial Acne
Conditions
Keywords
Ulthera® System, Ultherapy™ Treatment, Ulthera, Inc.
Brief summary
This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.
Detailed description
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.
Interventions
DEVICEUlthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Sponsors
Ulthera, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in facial acne | 60 days post-treatment | Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in skin clarity | 180 days post-treatment | Measured using a digital imaging system comparing baseline and post-treatment images. |
| Reduction of sebum production | 180 days post-treatment | Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments. |
| Patient Satisfaction at 60 days | 60 day post-treatment | Patient satisfaction as determined by completion of a patient satisfaction questionnaire. |
| Patient Satisfaction at 180 days | 180 Days post-treatment | Patient satisfaction as determined by completion of patient satisfaction questionnaire. |
Countries
United States
Outcome results
None listed