Status:
COMPLETED
Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne
Lead Sponsor:
Oregon Aesthetic Technologies
Conditions:
Acne
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01162837
Start Date
June 1 2010
End Date
October 1 2010
Last Update
May 3 2012
Active Locations (3)
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1
Baumann Cosmetic & Research Institute
Miami Beach, Florida, United States, 33140
2
Grekin Skin Institute
Warren, Michigan, United States, 48088
3
Oregon Dermatology & Research Institute
Portland, Oregon, United States, 97210