Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne
Completed · Not applicable
Conditions studied: Acne
In brief
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.
Key facts
- Study ID
- NCT01162837
- Run by
- Oregon Aesthetic Technologies
- People needed
- 33
- Starts
- 2010-06-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2012-05-03
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Baumann Cosmetic & Research Institute — Miami Beach, Florida, United States
- Grekin Skin Institute — Warren, Michigan, United States
- Oregon Dermatology & Research Institute — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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