- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00355485
Microdermabrasion for Acne
Microdermabrasion for Acne Vulgaris
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Microdermabrasion Treatment
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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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.
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Subject self-assessment questionnaire
Time Frame: At end of treatment phase.
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At end of treatment phase.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Darius Karimipour, MD, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Derm 563
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