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

NCT ID: NCT01160757

Last Updated: 2010-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ultrasound

Group Type OTHER

ultrasound

Intervention Type DEVICE

ultrasound exposure on acute acne lesions

Interventions

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ultrasound

ultrasound exposure on acute acne lesions

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Arizona State University, College of Nursing and Healthcare Innovation

Principal Investigators

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Denise Link, PhD

Role: PRINCIPAL_INVESTIGATOR

ASU, College of Nursing and Healthcare Innovation

Locations

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Arizona State University, College of Nursing and Healthcare Innovation

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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U/S1-SPOT

Identifier Type: -

Identifier Source: org_study_id

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