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

Facial Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591304
• Other study ID #: ULT-116
• Status: Completed
• Phase: N/A
• First received: April 27, 2012
• Last updated: November 21, 2017
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: December 2014
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Acne
• Facies

Intervention

Device:
• Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.

Locations

Country	Name	City	State
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	Multispecialty Aesthetic Clinical Research Organization	Woodland Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in facial acne	Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.	60 days post-treatment
Secondary	Change from baseline in skin clarity	Measured using a digital imaging system comparing baseline and post-treatment images.	180 days post-treatment
Secondary	Reduction of sebum production	Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.	180 days post-treatment
Secondary	Patient Satisfaction at 60 days	Patient satisfaction as determined by completion of a patient satisfaction questionnaire.	60 day post-treatment
Secondary	Patient Satisfaction at 180 days	Patient satisfaction as determined by completion of patient satisfaction questionnaire.	180 Days post-treatment