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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 11, 2014