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

This study has been completed.
Sponsor:
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01160757
First received: July 9, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Device: ultrasound
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Time to clear acute acne lesions [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: October 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ultrasound Device: ultrasound
ultrasound exposure on acute acne lesions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 9, 2010
Last Updated: July 9, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014