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

Not Applicable

Completed

• Conditions: Acne

• Registration Number: NCT01162837
• Lead Sponsor: Oregon Aesthetic Technologies

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-15
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Global Acne Severity Score	8-weeks	Reduction in the Global Acne Severity Score at 8-weeks of treatment

Trial Locations

Locations (3)

Baumann Cosmetic & Research Institute; 🇺🇸 Miami Beach, Florida, United States

Grekin Skin Institute; 🇺🇸 Warren, Michigan, United States

Oregon Dermatology & Research Institute; 🇺🇸 Portland, Oregon, United States