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

May 1, 2012 updated by: Oregon Aesthetic Technologies

An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Baumann Cosmetic & Research Institute
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology & Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Acne Severity Score
Time Frame: 8-weeks
Reduction in the Global Acne Severity Score at 8-weeks of treatment
8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Aesthetic Technologies

Investigators

  • Principal Investigator: Ben Ehst, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAT-0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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