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

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

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

Conditions
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Acne

Intervention / Treatment
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* Device: BEAM device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All subjects<br>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 | Device: BEAM device<br>* A red/blue LED device for the treatment of acne<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Acne Severity Score | Reduction in the Global Acne Severity Score at 8-weeks of treatment | 8-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne