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Clinical Trials/NCT01160757
NCT01160757
Completed
Phase 1

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

Arizona State University1 site in 1 country35 target enrollmentOctober 2008
ConditionsAcne Vulgaris

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acne Vulgaris
Sponsor
Arizona State University
Enrollment
35
Locations
1
Primary Endpoint
Time to clear acute acne lesions
Status
Completed
Last Updated
15 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
July 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Time to clear acute acne lesions

Time Frame: 12 days

Study Sites (1)

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