Clinical trial NCT01591304: Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
Official title: Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Acne
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in facial acne
timeFrame: 60 days post-treatment
Secondary outcomes:
measure: Change from baseline in skin clarity
timeFrame: 180 days post-treatment
measure: Reduction of sebum production
timeFrame: 180 days post-treatment
measure: Patient Satisfaction at 60 days
timeFrame: 60 day post-treatment
measure: Patient Satisfaction at 180 days
timeFrame: 180 Days post-treatment
Other outcomes:
Locations:
city: Woodland Hills
country: United States
facility: Multispecialty Aesthetic Clinical Research Organization
state: California
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
Study officials:
affiliation: Dermatology, Laser & Vein Specialists of the Carolinas
name: Girish Munavalli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: