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

NCT01162837 | Completed

• 1 other identifier: OAT-0110
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acne

Keywords

Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Global Acne Severity Score

  8-weeks

Study Arms (1)

All subjects

OTHER

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

Interventions

BEAM device DEVICE

A red/blue LED device for the treatment of acne

All subjects

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.

Sponsors & Collaborators

• Oregon Aesthetic Technologies: lead

Study Sites (3)

Baumann Cosmetic & Research Institute

Miami Beach, Florida, 33140, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Oregon Dermatology & Research Institute

Portland, Oregon, 97210, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Ben Ehst, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (3)