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

Not Applicable

Completed

• Conditions: Facial Acne
• Interventions: Device: Ulthera System Treatment

• Registration Number: NCT01591304
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2014-12
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ulthera System Treatment	Ulthera System Treatment provided using 1.5mm and 1.0mm transducers, at 0.18J and 0.15J energy settings, respectively.
Group A	Ulthera System Treatment	Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.

Primary Outcome Measures

Name	Time	Method
Change from baseline in facial acne	60 days post-treatment	Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Multispecialty Aesthetic Clinical Research Organization; 🇺🇸 Woodland Hills, California, United States

Dermatology, Laser & Vein Specialists of the Carolinas; 🇺🇸 Charlotte, North Carolina, United States