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

Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne

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

Study Overview

• Status: Completed
• Conditions: Facial Acne
• Intervention / Treatment: Device: Ulthera System Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Woodland Hills, California, United States, 91367
      • Multispecialty Aesthetic Clinical Research Organization
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ulthera, Inc.; Ulthera® System; Ultherapy™ Treatment
Active Comparator: Group B; Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.	Device: Ulthera System Treatment; Focused ultrasound energy delivered below the surface of the skin.; Other Names: Ulthera, Inc.; Ulthera® System; Ultherapy™ Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in facial acne	Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.	60 days post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in skin clarity	Measured using a digital imaging system comparing baseline and post-treatment images.	180 days post-treatment
Reduction of sebum production	Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.	180 days post-treatment
Patient Satisfaction at 60 days	Patient satisfaction as determined by completion of a patient satisfaction questionnaire.	60 day post-treatment
Patient Satisfaction at 180 days	Patient satisfaction as determined by completion of patient satisfaction questionnaire.	180 Days post-treatment

Collaborators and Investigators

• Sponsor: Ulthera, Inc
• Investigators: Principal Investigator: Girish Munavalli, M.D., Dermatology, Laser & Vein Specialists of the Carolinas

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 27, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: ULT-116