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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01160757
• Other study ID #: U/S1-SPOT
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2010
• Last updated: July 9, 2010
• Start date: October 2008

Study information

• Verified date: July 2010
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• ultrasound
ultrasound exposure on acute acne lesions

Locations

Country	Name	City	State
United States	Arizona State University, College of Nursing and Healthcare Innovation	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clear acute acne lesions		12 days	Yes