Acne VulgarisPhase 2NCT00355485
Microdermabrasion for Acne
A Phase 2 study testing microdermabrasion in people with Acne Vulgaris, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- microdermabrasion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2007
- Phase
- Phase 2
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 13 years or older of either gender and of any racial/ethnic group.
- Presence of clinically evident acne vulgaris of the facial skin.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- Subjects must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Who cannot join
- Oral retinoid use within 6 months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study.
- Laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
- Use of topical lipid absorbing substances (Clinac AC) within 2 weeks 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 2 weeks 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: Microdermabrasion for Acne Vulgaris
The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.
Read the detailed description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. It has also been proposed to improve acne presumably through a comedolytic effect. Negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. Many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice.
We propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. We will use the Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
- Conditions
- Acne Vulgaris
- Being tested
- microdermabrasion
- Keywords
- Acne, Microdermabrasion
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microdermabrasionDevice
Device: Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Microdermabrasion Treatment | Experimental | Bilateral, split-face comparison in which one half of the face will be randomly assigned to receive the microdermabrasion treatment(s) while the other half of the face will not. Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart. In all cases, microdermabrasion treatment parameters will be within those accepted in cosmetic work. Receives: Device: microdermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts of specific types of acne lesions.
Measured: These lesions will be counted at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.
Secondary outcomes (2)
Clinical photographs
Measured: Photographs may be obtained at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.
Subject self-assessment questionnaire
Measured: At end of treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Investigators
- John J Voorhees, MD, Study chair, University of MichiganDarius Karimipour, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355485
- Sponsor's protocol ID
- Derm 563
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2006
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdermabrasion for Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00355485
- Acronym / sponsor ID
- Derm 563
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Microdermabrasion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 24 Jul 2006 (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.
The purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. The microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.
Detailed description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. It has also been proposed to improve acne presumably through a comedolytic effect. Negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. Many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice.
We propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. We will use the Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microdermabrasion Treatment | Experimental | Device: microdermabrasionBilateral, split-face comparison in which one half of the face will be randomly assigned to receive the microdermabrasion treatment(s) while the other half of the face will not. Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart. In all cases, microdermabrasion treatment parameters will be within those accepted in cosmetic work. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 13 years or older of either gender and of any racial/ethnic group.
- Presence of clinically evident acne vulgaris of the facial skin.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
- Subjects must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Key exclusion criteria (11 listed)
- Oral retinoid use within 6 months of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study.
- Laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites 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 |
|---|---|---|
| microdermabrasionDevice: Bellamed microdermabrasion system produced by Bella products or the Altair Diamondtome System. Subjects will receive a series of microdermabrasion treatment sessions (up to 6) spaced one to two weeks apart. | Device | Microdermabrasion Treatment |
Primary outcome
Counts of specific types of acne lesions.
Time frame: These lesions will be counted at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.
2 secondary outcomes
Clinical photographs
Time frame: Photographs may be obtained at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 weeks.
Subject self-assessment questionnaire
Time frame: At end of treatment phase.
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 10 Jul 2015.
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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.
John J Voorhees, MD study chair
University of Michigan
Darius Karimipour, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing microdermabrasion in people with Acne Vulgaris, run by University of Michigan at 1 site 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 11 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 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Counts of specific types of acne lesions. (time frame: These lesions will be counted at baseline, at follow-up evaluation visits during the treatment series, and every 1-4 weeks following the final treatment for a total of up to 18 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 10 Jul 2015.