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A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions

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ClinicalTrials.gov Identifier: NCT01160757
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Arizona State University

Brief Summary:
The purpose of this study is to find out how effective and safe an experimental ultrasound device is for treating Acute Acne lesions.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: ultrasound Phase 1

Detailed Description:

Acne vulgaris is a disease that occurs when oil and dead skin cells clog the pores of the skin. When the skin's pores are clogged, red spots and bumps known as pimples are formed, usually on the face, neck, chest, and back. In adolescents and adults, acne vulgaris is commonly called "acne." Many factors have been associated with acne. One of the factors is the increased production of fatty substances from an enlarged sebaceous gland ("oil gland").

The experimental ultrasonic device uses sound waves (called ultrasonic waves) to heat the acute acne lesion and the surrounding sebaceous ("oil") glands deep in the skin without affecting the surface of the skin. We hope that heating the sebaceous glands will reduce their size and reduce the symptoms of inflamed acne. Using ultrasonic waves to treat acne is investigational.

This is a pilot study. A pilot study is done on a small group of subjects to learn if the device will be effective and safe, before the device is used on a larger group of subjects.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions
Study Start Date : October 2008
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
ultrasound Device: ultrasound
ultrasound exposure on acute acne lesions



Primary Outcome Measures :
  1. Time to clear acute acne lesions [ Time Frame: 12 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female or male subjects,
  • greater than 18 years age,
  • with acute acne on the face.

Exclusion Criteria:

  • pregnancy,
  • concomitant skin diseases,
  • severe acne,
  • antibiotic therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160757


Locations
United States, Arizona
Arizona State University, College of Nursing and Healthcare Innovation
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Investigators
Principal Investigator: Denise Link, PhD ASU, College of Nursing and Healthcare Innovation

Responsible Party: Denise G. Link, PhD, WHNP-BC, CNE, FNAP, Associate Dean, Arizona State University, College of Nursing and Healthcare Innovation
ClinicalTrials.gov Identifier: NCT01160757     History of Changes
Other Study ID Numbers: U/S1-SPOT
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases