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Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne

This study has been completed.
Information provided by (Responsible Party):
Oregon Aesthetic Technologies Identifier:
First received: July 13, 2010
Last updated: May 1, 2012
Last verified: May 2012
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.

Condition Intervention
Device: BEAM device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne

Resource links provided by NLM:

Further study details as provided by Oregon Aesthetic Technologies:

Primary Outcome Measures:
  • Reduction in inflammatory lesion count [ Time Frame: 8 weeks ]
    Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment.

Secondary Outcome Measures:
  • Global Acne Severity Score [ Time Frame: 8-weeks ]
    Reduction in the Global Acne Severity Score at 8-weeks of treatment

Enrollment: 33
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All subjects
All subjects are enrolled in this arm and will use the BEAM device on one side of the face and the other side of the face will be the control
Device: BEAM device
A red/blue LED device for the treatment of acne


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 15 years or older of either gender and of any racial/ethnic group.
  2. At least 8 acne inflammatory lesions (see section 9) in the treatment and control areas.
  3. Presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the Global Acne Severity Scale, see below)
  4. Subjects must be in generally good health.
  5. Subjects must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Oral retinoid use within six months of entry into the study.
  2. Systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study.
  3. Topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study.
  4. Microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study.
  5. Subjects with a history of dermabrasion or laser resurfacing at the site to be treated.
  6. Use of topical lipid absorbing substances (Clinac AC) within 1 week of entry into the study.
  7. Non-compliant subjects.
  8. Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
  9. Subjects using alcohol-based topical solutions or "exfoliating" agents within 1 week of entry into the study.
  10. Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
  11. Pregnant or nursing females.
  12. Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
  13. Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01162837

United States, Florida
Baumann Cosmetic & Research Institute
Miami Beach, Florida, United States, 33140
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Oregon
Oregon Dermatology & Research Institute
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Oregon Aesthetic Technologies
Principal Investigator: Ben Ehst, MD Oregon Health and Science University
  More Information

Responsible Party: Oregon Aesthetic Technologies Identifier: NCT01162837     History of Changes
Other Study ID Numbers: OAT-0110
Study First Received: July 13, 2010
Last Updated: May 1, 2012

Keywords provided by Oregon Aesthetic Technologies:
Acne processed this record on April 26, 2017