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

Ulthera

Status: Completed

Conditions: Facial Acne

Treatments: Device: Ulthera System Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591304

ULT-116

Details and patient eligibility

About

This study will evaluate the effectiveness of Ultherapy for the treatment of facial acne.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group A

Active Comparator group

Description:

Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.

Treatment:

Device: Ulthera System Treatment

Group B

Active Comparator group

Description:

Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.

Treatment:

Device: Ulthera System Treatment