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

Ulthera, Inc24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Facial Acne

Interventions

Ulthera System TreatmentDEVICE

Focused ultrasound energy delivered below the surface of the skin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Multispecialty Aesthetic Clinical Research Organization

Woodland Hills, California, United States

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change from baseline in facial acne

Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.

Time frame: 60 days post-treatment

Secondary Outcomes

Change from baseline in skin clarity

Measured using a digital imaging system comparing baseline and post-treatment images.

Time frame: 180 days post-treatment

Reduction of sebum production

Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.

Time frame: 180 days post-treatment

Patient Satisfaction at 60 days

Patient satisfaction as determined by completion of a patient satisfaction questionnaire.

Time frame: 60 day post-treatment

Patient Satisfaction at 180 days

Patient satisfaction as determined by completion of patient satisfaction questionnaire.

Time frame: 180 Days post-treatment

Data from ClinicalTrials.gov

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