Infusion Of Active Substances With Micro-Needling

Whilst the moral of these stories may appear to be “watch what you inject into the skin”, the reality is much more complex with far greater consequences to be considered.

When Things Go Wrong

All too frequently we come across industry ‘disaster stories’ where a patient’s face or body has been injected with some product that quite simply was not designed for that purpose. Consider Rajee Narinesingh, whose face was injected with cement and tyre sealant. What resulted from a black market ‘plumping party’ she had attended in 2005 were heavy, rock- hard, dried cement nodules permanently embedded in her cheeks.

Monique Allen had over 12 litres of liquid plastic and silicone injected into her body in around 75 backstreet operations. Allen claimed, “the doctor would numb you then attach a funnel to whichever part of your body you wanted, then screw a vial of silicone on and pump it in”. Over the years, the silicone has migrated around her body, rendering her permanently disabled, with patches of disfiguring skin necrosis and ongoing infections.

Such scenarios however are not just limited to the lower socio-economic or blackmarkets, consider Daniel Tomas Fuente, an unlicensed medical practitioner in the USA (though a doctor in his native Argentina) who was operating an injectables clinic out of the bathroom of Lionel Richie’s then wife.

His injection of unapproved “anti-wrinkle” cocktails into his celebrity clientele, resulted in a bevy of complications, including nodules affecting facial movement and what one patient described as permanent “holes” in their face around the site of injection. Dr Daniel’s patient’s included Diane Richie, Priscilla Presley and Shawn King (the wife of Larry King).

The relationship between injections and micro-needling substances into the skin is far closer than many of us may think.

Micro-Needling & Dermal Infusion

In 2015, RXI Pharmaceuticals (a Massachusetts based biotechnology company focused inthe development of dermatology drugs), performed a study evaluating how effectively substances could be infused into the skin via micro-needling. For this independent study, a Dermapen 3 automated needling device was used to infuse a water-based marking dye into real skin.

“What this study concluded can only be described as simultaneously fascinating and frightening.”

Following the procedure, the samples were then processed for histology/biopsy. What this study concluded can only be described as simultaneously fascinating and frightening.

What this study proves is that the puncture channels created by micro-needling DO deliver active substances beyond the acid mantle into the lower layers of the dermis. In short, needling can be more effective than injection to disperse and saturate certain agents into the skin.

The homecare needling market (using rollers or automated devices) has always capitalised on the hope that it will ‘deliver’ one’s favourite topical skin care product deeper into the skin. This has then fuelled an alarming trend across both the homecare and professional aesthetics markets where ‘any old’ product is physically punctured, pushed and implanted into the skin with the hope for a deeper absorption and greater result. Nothing could be further from the truth with this risky practice.

Image 1 shows that under normal circumstances, a topically applied solution (think ampoules, serums, masks and moisturisers) cannot break through the skin’s
barrier function (also known as the acid mantle).

Image 2 is the same volume of solution on the same surface area that has been needled into the skin using a Dermapen 3, at speed 4 at a depth of 1mm with
multiple passes.

*Images courtesy of RXI Pharmaceuticals, Dermapen evaluation for delivery to the skin, December 2015, Massachusetts USA

Micro-needling & Infusion Risks

In 2013, USA based dermatologist Razieh Soltani-Arabshahi observed patients who had developed facial granulomas following a micro-needling procedure for
skin rejuvenation. A granuloma is a collection of granulation tissue formed in response to infection, chronic inflammation and the presence of foreign bodies.

Soltani-Arabshahi noted that biopsies of the skin of all patients presented “foreign type granulomas”. Soltani-Arabshai further noted “In cosmetic practices, various cosmeceuticals are applied before microneedling to enhance the therapeutic effects. This results in intradermal tattooing of the topical product. Despite rapid increase in the use of microneedles in dermatology, there are few data about their safety”.

2 of the patients in the study were subsequently treated with topical and oral corticosteroids with no success, they were then prescribed doxycycline hydrochloride and minocycline hydrochloride anti-biotics.

If left untreated, granulomas have the potential to form into nodules and create the deposition of fibrous tissue.

Soltani-Arabshai concluded “Application of topical products prior to microneedling can introduce immunogenic particles into the dermis and potentiate local or systemic hypersensitivity reactions”. In other words, products which possess a large molecular weight or which are not designed for infusion into the skin appear to pose an almost guaranteed risk. These risks include granulomatous reaction, papules, nodules and scar tissue.

Here are the post-operative effects experienced by three participants of the study:

*Images courtesy of Dr Razieh Soltani-Arabshahi et al., Facial allergic granulomatous reaction and systemic hypersensitivity associated with micro-needling for skin rejuvenation, JAMA Dermatol., 2014.150(1):68-72

What these two studies (RXI Pharmaceuticals and Soltani-Arabshahi) conclude are paramount for ANY practitioner who is needling with a roller, tattoo gun
or automated needling device:

  • If you needle a product into the skin, IT WILL GO IN.
  • If the product you needle into the skin is only designed for topical application or has not been molecularly weighted for infusion, IT WILL CREATE AN ADVERSE REACTION
  • Needling inappropriate products into the skin statistically WILL contribute to the formation of INFECTION, GRANULOMAS, NODULES AND THE FORMATION OF
  • Just because YOU CAN needle something into the skin, doesn’t mean YOU SHOULD

Whilst Rajee Narinesingh, Monique Allen and patients of ‘Dr Daniel’ were injected with inappropriate substances, patient risk and danger remains just as high when inappropriate substances are punctured, implanted, infused, placed and forced into the skin using any form of micro-needling device.

As the images from RXI Pharmaceuticals indicate, needling with a Dermapen 3 can infuse and saturate the dermis with an active substance with potential greater distribution than injection alone. At full speed, a Dermapen 3 delivers 1296 puncture channels a second into the skin – no needle on a syringe can compete with that.

Mesotherapy & Molecular Weighting

Coined as a term in France in 1958, mesotherapy is multiple injections of pharmaceutical grade actives into the skin. Not only are the actives selected and laboratory-manipulated to ensure skin affinity when injected or infused, but the actives are molecularly weighted to enable free movement in the skin without accumulating, becoming stuck or causing granulomas.

Superficial fillers (designed for hydration) and vitamin injections (for skin boosting and rejuvenation) are common forms of mesotherapy, these may only be performed by a medical practitioner. Unlike hyaluronic acid found in deeper fillers which iscross-linked to create volume, density and duration, the actives used in mesotherapy are not cross-linked to promote easy flow and flexibility.

Products designed for injection or for infusion (via micro-needling) adhere to strict criteria ensuring their safety not just ON the skin but IN the skin as well.

Molecular weighting of an active ingredient is paramount to virtually remove the risk of granulomas, nodules or formation of scar tissue. The system that measures atomic mass or molecular weighting of a substance is known as a Dalton.

For tiny structures such as peptides, proteins and hyaluronic acid, these are measured by kilodaltons (kDA) which are 1000 Daltons. The lower the number, the smaller the molecular weight. The higher the number, the larger the molecular weight.

Before using an ampoule, serum, cream or product as a procedural glide or to infuse into the skin during a micro-needling treatment, here are questions you must ask to ensure procedural safety and patient duty of care.

Likewise, the same questions should also be asked of any product representative trying to convince you to use their product line for your micro-needling procedures. If you or they cannot deliver an acceptable answer for ANY of these questions, DON’T TAKE THE RISK and find something more suitable for use.

  • What is the name of the measurement system used to determine the molecular weight of a substance?
  • What is the average molecular weight of the product you wish to infuse into the skin?
  • Is the product specifically designed for injection or for infusion with skin needling?
  • Are the active ingredients safe to be infused physically into the skin with no harm?
  • Is product purity ensured via aseptic or sterile packaging? What is the preservation system to ensure ingredient stability and activity?

Dp Dermaceuticals – A World First

In 2010, Dermapenworld teamed up with the Matrix Biology Institute to create Hyla Active, the world’s first meso-infusion exclusively designed for micro-needling
procedures. Based in New Jersey, the Matrix Biology Institute are the world’s leading research and development laboratories for medical and aesthetic hyaluronic acid.

Their patented technology features in not only in the world’s foremost and notable injectables but also in DP Dermaceuticals. The Hyla-Fuse complex features
in every DP Dermaceuticals product (including Hyla Active) and is a triple molecular weighted hyaluronic acid designed as a standalone active and as an encapsulating delivery system for safe infusion INTO the skin.

The largest molecular weight is just 1800kDA, the medium 1500kDA and the smallest as minuscule as 10kDA. The technology furthermore is non-crosslinked
to enable free and easy movement within the skin without the risk of granuloma or nodule formation.

The minuscule molecules can safely be needled into tissue for effortless and safe meso-infusion. Ethylhexylglycerinacid creates a non-volatile conservation
system that ensures intensity, purity and stability. The Hyla-Fuse complex is so safe, it can even be eaten.

An independent study performed by researchers at Monash University in Melbourne shows how molecularly weighted hyaluronic acid not only can break through
the skin’s acid mantle, but can travel as deep as reticular dermis, even with topical application.

In the below haematoxylin counterstain test, the same medium (1500kDA) and small (10-1000kDA) molecular weights of hyaluronic acid used in the Hyla-Fuse
Complex have been dyed a dark grey and applied topically to a human forearm.

On Image 1, a biopsy shows absorption of the medium molecular weight down to basal epidermis. On Image 2, the smallest molecular weight has absorbed down
to reticular dermis following just 20 minutes of application. This level of absorption cannot be achieved without laboratorical manipulation of hylaronic
acid’s atomic mass.

Image 1

Image 2

*Images courtesy of Brown et al, J. Invest Dermatol 113:740-746, Haematoxylin Counterstain Clinical, “Absorption Of Hyaluronan Applied To The Surface Of Intact Skin”, Monash University, Melbourne, Australia, 1999

It is for this reason that not all hyaluronic acids are the same. As with fillers, the laboratorical manipulation and molecular weighting of the Hyla Fuse
Complex is a complicated process. This type of technology is not easily replicated nor readily available. Substituting Dp Dermaceuticals during ANY
micro-needling procedure can be likened to Rajee Narinesingh’s face being injected with cement and tyre sealant – cutting corners greatly increases
procedural risk and patient dissatisfaction.