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OpenTrials
Completed

NCT Number: NCT01162837

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

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

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baumann Cosmetic & Research Institute, Miami Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BEAM device

Device

A red/blue LED device for the treatment of acne

Primary outcomes

  1. Reduction in inflammatory lesion count

    Time frame: 8 weeks

    Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment.

Secondary outcomes

  1. Global Acne Severity Score

    Time frame: 8-weeks

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

Sponsors and collaborators

Lead sponsor

Oregon Aesthetic Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 15, 2010
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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