Monday, September 25, 2017

Microneedling with Dermaroller or DermaPen

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Photodamage and the aging process damage the layers of the skin. Wrinkles appear due to loss of structural matrix components outside skin cells (collagen and elastin), dehydration from loss of hyaluronic acid (HA) in the tissue and overall thinning of superficial epidermal and deep dermal skin layers. Microneedling with a dermaroller involves rolling a cylindrical drum with fine needles over the skin surface.
DERMAROLLER

These rollers are available from online vendors, drug store chains and department stores for home use. The needle size ranges from 0.25mm up to 2mm in diameter and various lengths. Some rollers come with interchangeable heads containing different needle sizes. The needles are embedded in a rotating cylinder that can hold up to 200 needles. By rolling the device over the skin the needles create minuscule holes that close within minutes after the treatment without any visible traces in the epidermis or stratum corneum layers of the skin. A hand held pen with oscillating needles is also available for physician use called DermaPen. Each puncture creates a micro-channel in each punctured layer with a surrounding micro-area of inflammation (accumulation of immune cells such as neutrophils and macrophages) in response to the injury. A healing cell proliferating process follows with formation of new small blood vessels/capillaries, replenishment of structural matrix components (collagen, proelastin, hyaluronic acid, glycosaminoglycans like glucoseamine) by recruited fibroblast cells and surface skin cells growing of the small holes. 6 to 8 weeks after a single treatment 1.1 to 10 fold increases in skin elastin have been found as well as new collagen formation and increased dermal thickness.

The right photo depicts needle depth and changes seen under the microscope 6 weeks after the procedure. The purple stain shows increased collagen in the dermal skin layer and the red areas at the level of the needle tip show newly formed small blood vessels. A remodeling phase follows the completion of healing where contraction of the wound leads to skin tightening and increased tissue integrity. The result is improved tissue hydration, thickness and tightness of the treated areas with evening out of the pigmentation i.e. rejuvenation. The treatment is recommended for scars, acne scars, stretch marks, wrinkles, and for facial rejuvenation. It can also be used to improve the delivery of medications through the skin such as Rogaine applied topically for scalp hair loss. The device can be rolled over the forehead, nose, cheeks, scalp etc.


A study using 0.25mm wide 1.5mm long needles in 3 treatments each 3 months apart for acne scarring showed improvement in skin pigmentation, smoothness and texture. The advantage of the modality over CO2 lasers is the absence of heat making it more applicable for darker skinned individuals. Different needles lengths/depths can reach targeted anatomic layers of the skin depending on which area of the body is being treated. Depending on the body location, the epidermis skin layer can range anywhere from 0.05 mm to 1.5 mm. The dermis layer can range from 0.5 mm to 3 mm. Different areas of the face can have different skin thickness, which can also vary depending on age, race, gender and lifestyle (smoker, sunbather etc).

Microneedling should not be used on patients with scleroderma, collagen vascular disease or active bacterial or fungal infection or a history of keloid scars. Treatment regimens and needle size depend on areas to be treated, individual skin characteristics and condition being treated. A 4-week interval between treatments with a cycle of 3 treatments may be used to treat fine wrinkles. Acne scarring, may require upwards of 6 treatments. Maintenance treatments may be required at 6 months to 1 year intervals.

On September 14, 2017 The US Food and Drug Administration (FDA) issued a draft guidance that it considers "microneedling" products to be medical devices and subject to regulation. They cited justification for this being that the devices are associated with a number of risks, including infection, nerve and blood vessel damage, disease transmission, scarring and allergic reactions.

Whether such products are devices largely falls on their intended use, the manufacturer's claims and the size, sharpness and arrangement of the needles i.e. depth of penetration. Specific claims that would meet the definition of a medical device include:

  • Treats scars (e.g., acne scars, atrophic scars, hypertrophic scars, burn scars)
  • Treats wrinkles and deep facial lines
  • Treats cellulite and stretch marks
  • Treats dermatoses
  • Treats acne
  • Treats alopecia (hair loss)
  • Stimulates collagen production
  • Stimulates angiogenesis (blood vessel growth)
  • Promotes wound healing
Which covers about everything you would use the devices for. 

Manufacturers looking to market microneedling products that meet FDA's definition of a device will need to look to FDA's de novo pathway, as FDA considers microneedling devices to be a new type of device not previously cleared or suitable for a 510(k). 

In order to receive clearance, the FDA says manufacturers will need to detail the technical specifications of their device, including its needle characteristics and biocompatibility information and will need usability testing data, sterilization information and cleaning/disinfection details if the device is reusable. 
And depending on the manufacturer's claims, the FDA says clinical studies may be necessary to demonstrate safety and effectiveness. The larger more efficacious needle rollers may not be as readily available as they currently are for much longer and will likely be restricted to doctors offices with once use disposable heads.
FDA draft guidance on microneedling


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