A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions
|ClinicalTrials.gov Identifier: NCT01160757|
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 12, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Device: ultrasound||Phase 1|
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)|
|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|
|Primary Completion Date :||July 2009|
ultrasound exposure on acute acne lesions
- Time to clear acute acne lesions [ Time Frame: 12 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160757
|United States, Arizona|
|Arizona State University, College of Nursing and Healthcare Innovation|
|Phoenix, Arizona, United States, 85004|
|Principal Investigator:||Denise Link, PhD||ASU, College of Nursing and Healthcare Innovation|