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

Acne Clinical Trial

Official title:

An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162837
• Other study ID #: OAT-0110
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: May 1, 2012
• Start date: June 2010
• Est. completion date: October 2010

Study information

• Verified date: May 2012
• Source: Oregon Aesthetic Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Device:
• BEAM device
A red/blue LED device for the treatment of acne

Locations

Country	Name	City	State
United States	Baumann Cosmetic & Research Institute	Miami Beach	Florida
United States	Oregon Dermatology & Research Institute	Portland	Oregon
United States	Grekin Skin Institute	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Aesthetic Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in inflammatory lesion count	Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment.	8 weeks	No
Secondary	Global Acne Severity Score	Reduction in the Global Acne Severity Score at 8-weeks of treatment	8-weeks	No