Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne
This study has been completed.
Sponsor:
Oregon Aesthetic Technologies
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Age 15 years or older of either gender and of any racial/ethnic group.
- At least 8 acne inflammatory lesions (see section 9) in the treatment and control areas.
- Presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the Global Acne Severity Scale, see below)
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
Exclusion Criteria:
- Oral retinoid use within six months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study.
- Topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study.
- Microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the site to be treated.
- Use of topical lipid absorbing substances (Clinac AC) within 1 week of entry into the study.
- Non-compliant subjects.
- Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
- Subjects using alcohol-based topical solutions or "exfoliating" agents within 1 week of entry into the study.
- Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- Pregnant or nursing females.
- Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
- 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 May 19, 2013