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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01160757
Enrollment
35
Registered
2010-07-12
Start date
2008-10-31
Completion date
Unknown
Last updated
2010-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DEVICEultrasound

ultrasound exposure on acute acne lesions

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Time to clear acute acne lesions12 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026