Skin Wrinkling Clinical Trial
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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