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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ulthera, Inc
ClinicalTrials.gov Identifier:
NCT01591304
First received: April 27, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Facial Acne
Device: Ulthera System Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study: Evaluation of the Safety and Effectiveness of the Ulthera® System for the Treatment of Moderate to Severe Facial Acne

Resource links provided by NLM:


Further study details as provided by Ulthera, Inc:

Primary Outcome Measures:
  • Change from baseline in facial acne [ Time Frame: 60 days post-treatment ] [ Designated as safety issue: No ]
    Determined by a reduction in inflammatory and non-inflammatory lesion counts from baseline.


Secondary Outcome Measures:
  • Change from baseline in skin clarity [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    Measured using a digital imaging system comparing baseline and post-treatment images.

  • Reduction of sebum production [ Time Frame: 180 days post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient satisfaction as determined by completion of a patient satisfaction questionnaire.

  • Patient Satisfaction at 180 days [ Time Frame: 180 Days post-treatment ] [ Designated as safety issue: No ]
    Patient satisfaction as determined by completion of patient satisfaction questionnaire.


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.
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® System
  • Ultherapy™ Treatment
  • Ulthera, Inc.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591304

Locations
United States, California
Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, United States, 91367
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Ulthera, Inc
Investigators
Principal Investigator: Girish Munavalli, M.D. Dermatology, Laser & Vein Specialists of the Carolinas
  More Information

No publications provided

Responsible Party: Ulthera, Inc
ClinicalTrials.gov Identifier: NCT01591304     History of Changes
Other Study ID Numbers: ULT-116
Study First Received: April 27, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ulthera, Inc:
Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.

Additional relevant MeSH terms:
Acne Vulgaris
Facies
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014