Acne
Conditions
Keywords
Acne
Brief summary
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.
Interventions
DEVICEBEAM device
A red/blue LED device for the treatment of acne
Sponsors
Oregon Aesthetic Technologies
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in inflammatory lesion count | 8 weeks | Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Acne Severity Score | 8-weeks | Reduction in the Global Acne Severity Score at 8-weeks of treatment |
Countries
United States
Outcome results
None listed