Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111254
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-05-18
Brief Title:
The Effects of Microdermabrasion on Skin Remodeling
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effects of Microdermabrasion on Collagen and Elastin Biosynthesis
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hipbuttock 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 andor forearm andor 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 andor untreated skin from the buttocks forearm andor 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
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 hipbuttock 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 andor forearm andor 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 andor untreated skin from the buttocks forearm andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None