Healthy SkinNCT00111254
The Effects of Microdermabrasion on Skin Remodeling
A study testing Microdermabrasion in people with Healthy Skin and Skin Wrinkling, run by University of Michigan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin, Skin Wrinkling
- What is being tested?
- Microdermabrasion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jul 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: The Effects of Microdermabrasion on Collagen and Elastin Biosynthesis
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.
Read the detailed description
Microdermabrasion is rapidly becoming one of the most popular cosmetic procedures performed by dermatologists and plastic surgeons. Microdermabrasion is a process that uses a high-pressure stream of aluminum oxide crystals and negative pressure to superficially peel the upper layer of the skin. Its purported benefits include improvement of photoaged skin, acne, and facial scarring.
The appeal of microdermabrasion is its effectiveness, simplicity, low patient and operator risk, and rapid recovery. Clinically, studies have illustrated beneficial effects on photodamaged skin.
Histologically, microdermabrasion has reproducible effects on the epidermis and dermis. Studies have shown a consistent increase in epidermal thickness as well as changes in the elastin content of the dermis while changes in collagen content have not been observed.
The reported clinical and histologic changes seen in previous studies suggest that alterations in the dermis precipitated by epidermal injury may be responsible for the beneficial effects of microdermabrasion on photoaging and scarring. In fact, others have reported that skin fibroblasts under tension may increase collagen synthesis.
Disruption of the epidermal barrier initiates a repair process that restores barrier function within hours to days, depending on the severity of the damage. This repair process involves increased synthesis of barrier lipids, followed by formation of new corneocytes. Elevated lipid synthesis largely occurs as a result of increased gene expression of the major enzymes responsible for lipid biosynthesis.
In this study, subjects will be assigned to one of two treatment groups. Patients in the first group will have their hip/buttock or forearm treated with the microdermabrasion machine. There may be only one treatment or as many as 6 on the same area, spaced up to two weeks apart. The treated area will be on either the right or left buttock and/or forearm and/or underarm. An area of approximately 10x10 cm (4x4 inches) will be treated. Skin biopsies will be performed on up to nine different times, up to six months following dermabrasion, on treated and/or untreated skin from the buttocks, forearm and/or underarm. Therefore, a total of (up to) nine biopsies will be taken from subjects in this group. The biopsies will be 4 mm or smaller in size, or about the size of a pencil eraser. Subjects can expect to make six visits to the hospital over a 3-4 week period of time.
Subjects assigned to the second group will have their face treated with microdermabrasion at a weekly to biweekly interval for a total of six treatments. One pair of biopsies will be taken prior to the first treatment, and the 2nd and 3rd pair will be taken on two different occasions no later than 3 months following the final treatment. Thus, the maximum number of biopsies in group II is six. The biopsies will be 2mm punch, "cookie-cutter", biopsies and will be taken from in front of the ear. Subjects can expect to make 8-10 visits to the hospital over a 2-3 month period of time.
- Conditions
- Healthy Skin, Skin Wrinkling
- Being tested
- Microdermabrasion
- Keywords
- microdermabrasion, skin, wrinkles, collagen, photoaging, wrinkled skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodermabrasionProcedure or surgery
Treatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In 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. Receives: Procedure: Microdermabrasion |
| 2 | Experimental | In 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. Receives: Procedure: Microdermabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Group I: 1-4 weeks; Group II: 1-3 months
Secondary outcomes (1)
Changes in clinical features associated with sun-damaged or wrinkled skin.
Measured: Group I: 1-4 weeks, Group II: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startJun 2002
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SkinStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 257 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 Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111254
- Sponsor's protocol ID
- Derm 486
- Status last verified
- Jun 2011
- First submitted
- 18 May 2005
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19841398
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Microdermabrasion on Collagen and Elastin Biosynthesis
- ClinicalTrials.gov ID
- NCT00111254
- Acronym / sponsor ID
- Derm 486
- Conditions
- Healthy Skin, Skin Wrinkling
- Keywords
- microdermabrasion, skin, wrinkles, collagen, photoaging, wrinkled skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 May 2005 (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 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.
Detailed description
Microdermabrasion is rapidly becoming one of the most popular cosmetic procedures performed by dermatologists and plastic surgeons. Microdermabrasion is a process that uses a high-pressure stream of aluminum oxide crystals and negative pressure to superficially peel the upper layer of the skin. Its purported benefits include improvement of photoaged skin, acne, and facial scarring.
The appeal of microdermabrasion is its effectiveness, simplicity, low patient and operator risk, and rapid recovery. Clinically, studies have illustrated beneficial effects on photodamaged skin.
Histologically, microdermabrasion has reproducible effects on the epidermis and dermis. Studies have shown a consistent increase in epidermal thickness as well as changes in the elastin content of the dermis while changes in collagen content have not been observed.
The reported clinical and histologic changes seen in previous studies suggest that alterations in the dermis precipitated by epidermal injury may be responsible for the beneficial effects of microdermabrasion on photoaging and scarring. In fact, others have reported that skin fibroblasts under tension may increase collagen synthesis.
Disruption of the epidermal barrier initiates a repair process that restores barrier function within hours to days, depending on the severity of the damage. This repair process involves increased synthesis of barrier lipids, followed by formation of new corneocytes. Elevated lipid synthesis largely occurs as a result of increased gene expression of the major enzymes responsible for lipid biosynthesis.
In this study, subjects will be assigned to one of two treatment groups. Patients in the first group will have their hip/buttock or forearm treated with the microdermabrasion machine. There may be only one treatment or as many as 6 on the same area, spaced up to two weeks apart. The treated area will be on either the right or left buttock and/or forearm and/or underarm. An area of approximately 10x10 cm (4x4 inches) will be treated. Skin biopsies will be performed on up to nine different times, up to six months following dermabrasion, on treated and/or untreated skin from the buttocks, forearm and/or underarm. Therefore, a total of (up to) nine biopsies will be taken from subjects in this group. The biopsies will be 4 mm or smaller in size, or about the size of a pencil eraser. Subjects can expect to make six visits to the hospital over a 3-4 week period of time.
Subjects assigned to the second group will have their face treated with microdermabrasion at a weekly to biweekly interval for a total of six treatments. One pair of biopsies will be taken prior to the first treatment, and the 2nd and 3rd pair will be taken on two different occasions no later than 3 months following the final treatment. Thus, the maximum number of biopsies in group II is six. The biopsies will be 2mm punch, "cookie-cutter", biopsies and will be taken from in front of the ear. Subjects can expect to make 8-10 visits to the hospital over a 2-3 month period of time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: MicrodermabrasionIn 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 | Experimental | Procedure: MicrodermabrasionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| MicrodermabrasionTreatment will consist of 3 passes in different directions (horizontal, vertical and oblique) with the microdermabrasion handpiece (Parisian Peel, Prestige model, medical microdermabrasion device). | Procedure or surgery | 1, 2 |
Primary outcome
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.
Time frame: Group I: 1-4 weeks; Group II: 1-3 months
1 secondary outcome
Changes in clinical features associated with sun-damaged or wrinkled skin.
Time frame: Group I: 1-4 weeks, Group II: 1-3 months
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 21 May 2015.
- Derived from this study: PubMed 19841398Karimipour 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.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Microdermabrasion in people with Healthy Skin and Skin Wrinkling, run by University of Michigan.
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 4 inclusion and 7 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 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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. (time frame: Group I: 1-4 weeks; Group II: 1-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00111254, which also lists 1 linked publication.
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 21 May 2015.