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

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ClinicalTrials.gov Identifier: NCT01162837
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : May 3, 2012
Sponsor:
Information provided by (Responsible Party):
Oregon Aesthetic Technologies

Study Description
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Brief Summary:
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.

Condition or disease Intervention/treatment Phase
Acne Device: BEAM device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Global Acne Severity Score [ Time Frame: 8-weeks ]
    Reduction in the Global Acne Severity Score at 8-weeks of treatment


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162837


Locations
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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
Investigators
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Principal Investigator: Ben Ehst, MD Oregon Health and Science University
More Information
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Responsible Party: Oregon Aesthetic Technologies
ClinicalTrials.gov Identifier: NCT01162837     History of Changes
Other Study ID Numbers: OAT-0110
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Keywords provided by Oregon Aesthetic Technologies:
Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases