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

Oregon Aesthetic Technologies

Status: Completed

Conditions: Acne

Treatments: Device: BEAM device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01162837

OAT-0110

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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33 participants in 1 patient group

All subjects

Other group

Description:

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

Treatment:

Device: BEAM device