Microdermabrasion for Acne
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| First Received Date ICMJE | July 21, 2006 | ||||||||
| Last Updated Date | June 2, 2011 | ||||||||
| Start Date ICMJE | September 2006 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Counts of specific types of acne lesions. | ||||||||
| Change History | Complete list of historical versions of study NCT00355485 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Microdermabrasion for Acne | ||||||||
| Official Title ICMJE | Microdermabrasion for Acne Vulgaris | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acne Vulgaris | ||||||||
| Intervention ICMJE | Device: microdermabrasion
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. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 24 | ||||||||
| Completion Date | April 2008 | ||||||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00355485 | ||||||||
| Other Study ID Numbers ICMJE | Derm 563 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Darius J. Karimipour, M.D., Clinical Assistant Professor, University of Michigan Department of Dermatology | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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