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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oregon Aesthetic Technologies
ClinicalTrials.gov Identifier:
NCT01162837
First received: July 13, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Acne
Device: BEAM device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162837

Locations
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
Principal Investigator: Ben Ehst, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Oregon Aesthetic Technologies
ClinicalTrials.gov Identifier: NCT01162837     History of Changes
Other Study ID Numbers: OAT-0110
Study First Received: July 13, 2010
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Aesthetic Technologies:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 16, 2014