PEER-REVIEW | MICRONEEDLING | Regulatory guidelines on national or European level,
which would regulate the safety requirements for intradermal accessory compounds of invasive cosmetic microneedling do not exist yet. From the view of the consumers,
the
practitioners, and the manufacturers,
it is
strongly advised to close this regulatory gap in parallel to the legal regulation for tattoo agents. The above
During the invasive
the epidermis is not injured across large areas but
mentioned regulatory gap is no reason for a limitation to cosmetic invasive microneedling. It is important to point out that a combination with accessory compounds is generally not required for an effective wrinkle smoothing with PCI through microneedling. If lubricants are desired for such a treatment, the usage of sterile compounds are recommended, which have been classified as uncritical, by the authors, when used during the pricking of the skin. For example, a sterile physiological saline solution could be used.
Definition of medical invasive microneedling An invasive microneedling treatment with a medical intended use, such as scar smoothing through PCI, is considered as a medical application, which has to be executed by a physician himself or an expert delegated by the physician. As the physiological change of diseased skin tissue will be indicated here, the usage of CE market medical devices is mandatory. However,
cosmetic
microneedling devices require the ‘general’ CE mark, complying with the machinery directive. The PCI-effect of medical
invasive microneedling can be optimized through additional topical or transdermal application of medical products in the relevant skin area. Thereby, it refers to pharmaceuticals according to the European pharmaceutical regulation 2001/83/EC or to medical devices according to the European medical device directive 93/42/EEC, which are approved for the use in the dermis.
References
1. Lee Y, Hwang K. Skin thickness of Korean adults. Surg Radiol Anat 2002; 24: 183-189
2. Krackowizer P, Brenner E. Dicke der Epidermis und Dermis. Phlebologie 2008; 37: 83-92
3. The US FDA (Food & Drug Administration) distinguishes the microneedling treatment from the
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cosmetic treatment through the penetration depth because medical care treatment is defined differently in the USA compared to Europe
4. Fernandes D (2002) Percutaneous collagen induction: an alternative to laser resurfacing. Aesthetic Surg 22: 315–317
5. Aust M C, Fernandes D, Kolokythas P, Kaplan H M, Vogt P M. Percutaneous Collagen Induction Therapy: An Alternative Treatment for Scars, Wrinkles, and Skin Laxity. Plast. Reconstr. Surg. 121: 1421, 2008
6. Camirand A, Doucet J (1997) Needle dermabrasion. Aesthetic Plast Surg 21: 48–51
7. Directive of the curriculum of beauty therapists from 9. January 2002
8. Directive of the bachelor’s curriculum of beauty therapists part I and II from 16. January 2015
9. Operationen- und Prozedurenschlüssel (OPS) 2015: 5-882.6 Plastische Rekonstruktion durch Tätowierung
remains intact between the microlesions, so that no structural weakening
occurs of the epidermal and dermal skin layers.
microneedling treatment
Conclusion For the treatment area ‘microneedling of the skin’ it can easily be shown how a technique can be regulated for medical as well as for non-medical treatments without causing safety risks to the patient or the consumer. Significant to the definition of when a
microneedling treatment should be supervised by a physician is not the level of invasion but the intended use of the treatment. By definition, a medical care treatment requires a patient who is treated with the intention to cure or improve his illness. It is the decision of the physician if and how the microneedling treatment might be delegated to an expert, such as a qualified beauty therapist. During the invasive microneedling treatment the
epidermis is not injured across large areas but remains intact between the microlesions, so that no
structural weakening occurs of the epidermal and dermal skin layers. Therefore, the treatment risk that arises from this invasive treatment technique, can be safely controlled by a qualified beauty therapist. From the view of the consumers, practitioners, and manufacturers it is, however, necessary to create clear guidelines for the safety requirements of intradermal accessory compounds for invasive microneedling on the national and European level. Cosmetic agents according to the Cosmetic Regulation 1223/2009/EC may not be combined with invasive microneedling treatments in line with their intended use because these compounds are only intended for the application on the surface of the skin.
Declaration of interest The author
Heinz Freier declares no support from any organisation for the
submitted work; The author Andreas Pachten received research grants and honorariums from
MT.DERM GmbH company. No other relationships or activities that could appear to have influenced the submitted work.
Figures 3 & 4 © MT DERM Key points Cosmetic
microneedling contributes to the wellness and beauty of the skin, whereas medical microneedling contributes to the improvement of the disease condition of the skin
The non-invasive
microneedling treatment of the epidermal barrier improves the
absorbability of the skin for the topically applied compounds
microneedling treatment on healthy or damaged skin in combination with a cosmetic product according to the cosmetic act 1223/2009/EC for the purpose of cosmetic skin care is regarded as a cosmetic application
microneedling treatment with a medical intended use (e.g. scar smoothing) is considered as a medical application, which has to be executed by a physician or an expert delegated by the physician
microneedling treatment of customers, for example performed for wrinkle smoothing, is considered as a cosmetic treatment
October 2015 |
prime-journal.com
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