The Effects of Microdermabrasion on Skin Remodeling
1 other identifier
interventional
257
0 countries
N/A
Brief Summary
This research project aims to study the effects of microdermabrasion, a technique causing minimal injury used to improve the appearance of fine lines, wrinkles, and scars. Subjects will undergo microdermabrasion, which is a gentle "sand-blasting" of the skin. We are interested in determining how this procedure works at rebuilding the skin following microdermabrasion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 18, 2005
CompletedFirst Posted
Study publicly available on registry
May 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMay 21, 2015
June 1, 2011
7.1 years
May 18, 2005
May 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Observing changes over time with respect to the following biochemical endpoints: Procollagen I and III, matrix metalloproteinases (MMPs 1, 3, and 9), and several cytokines including Interleukins and Tumor Necrosis Factor.
Group I: 1-4 weeks; Group II: 1-3 months
Secondary Outcomes (1)
Changes in clinical features associated with sun-damaged or wrinkled skin.
Group I: 1-4 weeks, Group II: 1-3 months
Study Arms (2)
1
EXPERIMENTALIn group I, acute effect group, each subject will undergo microdermabrasion of the hip/buttock. Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device). 4mm punch biopsies will be performed in the treated area at 4hrs, 8hrs, and 24hrs post-treatment. In addition, one 4mm punch biopsy will be obtained from adjacent untreated skin.
2
EXPERIMENTALIn group II, chronic effect group, each subject will undergo microdermabrasion of the face at weekly intervals for six weeks. Treatment will consist of 3 passes in different directions with the microdermabrasion handpiece (horizontal, vertical, and oblique). Aluminum oxide abrasion and negative pressure will be increased as tolerated by the patient. Two 2mm punch biopsies will be obtained prior to the first treatment and one week following the sixth treatment.
Interventions
Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device).
Eligibility Criteria
You may qualify if:
- Ages 18 or older
- Patients must be available for follow up visits for biopsies to comply with the requirements of the protocol.
- Patients must sign and understand the informed consent prior to participation in the study.
- You 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
You may not qualify if:
- Oral retinoid (vitamin-A like drugs) use within one year of entry into the study
- Topical retinoid use within 3 months of the study
- Patients with a history of excessive scarring
- Patients with significant medical history or concurrent illness which investigators feel is not safe for study participation
- Patients who have had any type of facial rejuvenation procedure or treatment (such as Botox injections, collagen implants, or chemical peels) within the past six months
- Non-compliant patients
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Karimipour DJ, Rittie L, Hammerberg C, Min VK, Voorhees JJ, Orringer JS, Sachs DL, Hamilton T, Fisher GJ. Molecular analysis of aggressive microdermabrasion in photoaged skin. Arch Dermatol. 2009 Oct;145(10):1114-22. doi: 10.1001/archdermatol.2009.231.
PMID: 19841398DERIVED
Study Officials
- STUDY CHAIR
John J Voorhees, MD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2005
First Posted
May 19, 2005
Study Start
June 1, 2002
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 21, 2015
Record last verified: 2011-06