AcneNCT01162837
Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne
A study testing BEAM device in people with Acne, run by Oregon Aesthetic Technologies at 3 sites in United States.
Trial summary
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne
- What is being tested?
- BEAM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baumann Cosmetic & Research Institute
Miami Beach, Florida, 33140
Oregon Dermatology & Research Institute
Portland, Oregon, 97210
Grekin Skin Institute
Warren, Michigan, 48088
About this study
Official title: An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of 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.
- Conditions
- Acne
- Being tested
- BEAM device
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEAM deviceDevice
A red/blue LED device for the treatment of acne
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: BEAM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in inflammatory lesion count
Reduction in the number of inflammatory acne lesions on one side of the face after 8 weeks of treatment.
Measured: 8 weeks
Secondary outcomes (1)
Global Acne Severity Score
Reduction in the Global Acne Severity Score at 8-weeks of treatment
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Aesthetic Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Ehst, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162837
- Sponsor's protocol ID
- OAT-0110
- Status last verified
- May 2012
- First submitted
- 13 Jul 2010
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne
- ClinicalTrials.gov ID
- NCT01162837
- Acronym / sponsor ID
- OAT-0110
- Conditions
- Acne
- Keywords
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oregon Aesthetic TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Device: BEAM deviceAll 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEAM deviceA red/blue LED device for the treatment of acne | Device | All subjects |
Primary outcome
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.
1 secondary outcome
Global Acne Severity Score
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Ehst, MD principal investigator
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEAM device in people with Acne, run by Oregon Aesthetic Technologies at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in inflammatory lesion count (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.