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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01591304
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc. ( Ulthera, Inc )

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date November 24, 2017
Study Start Date  ICMJE August 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Change from baseline in facial acne [ Time Frame: 60 days post-treatment ]
Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Improvement in facial acne [ Time Frame: 60 days post-treatment ]
Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.
Change History Complete list of historical versions of study NCT01591304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
  • Change from baseline in skin clarity [ Time Frame: 180 days post-treatment ]
    Measured using a digital imaging system comparing baseline and post-treatment images.
  • Reduction of sebum production [ Time Frame: 180 days post-treatment ]
    Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.
  • Patient Satisfaction at 60 days [ Time Frame: 60 day post-treatment ]
    Patient satisfaction as determined by completion of a patient satisfaction questionnaire.
  • Patient Satisfaction at 180 days [ Time Frame: 180 Days post-treatment ]
    Patient satisfaction as determined by completion of patient satisfaction questionnaire.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Improvement in skin clarity [ Time Frame: 180 days post-treatment ]
    Measured using a digital imaging system comparing baseline and post-treatment images.
  • Reduction of sebum production [ Time Frame: 180 days post-treatment ]
    Assessments using a sebumeter will be performed comparing pre-treatment and post-treatment assessments.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study: Ulthera® System for the Treatment of Moderate to Severe Facial Acne
Official Title  ICMJE Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Facial Acne
Intervention  ICMJE Device: Ulthera System Treatment
Focused ultrasound energy delivered below the surface of the skin.
Other Names:
  • Ulthera® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
Study Arms  ICMJE
  • Active Comparator: Group A
    Ulthera System Treatment provided using 1.5mm and 1.0mm transducers at 0.25J and 0.20J energy settings, respectively.
    Intervention: Device: Ulthera System 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.
    Intervention: Device: Ulthera System Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
30
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591304
Other Study ID Numbers  ICMJE ULT-116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz North America, Inc. ( Ulthera, Inc )
Study Sponsor  ICMJE Ulthera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Girish Munavalli, M.D. Dermatology, Laser & Vein Specialists of the Carolinas
PRS Account Merz North America, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP