| MICRONEEDLING | PEER-REVIEW
statistically significant improvement of responder rate of 66.7% for the toxin arm versus 6.7% for the placebo arm as assessed by the investigators as part of the primary outcome at day 30. Although an objective visual measurement tool such as the PRIMOS or Visia system was not used in the study, the facial wrinkle scale (FWS), is a scientifically validated tool, approved by the FDA for registration studies. Despite the above points and other limitations, such as
a lack of statistical powering, the exclusion of males, and lack of Fitzpatrick data, the results from this study are compelling in supporting the efficacy of Radara® in combination with HA serum to help improve the appearance of wrinkles within the CFL area. Although alternative MN devices have reported similar outcomes, this novel method of developing micro-channels has the benefit of being painless and requiring only 5 minutes of application per day, which the user can self administer. Radara® may therefore offer an effective treatment option in anti-ageing in conjunction with more traditional modalities such as botulinum toxin and dermal fillers. It may be best to describe an option such as this as ‘maintenance therapy’, opening up a new era in cosmeceuticals.
Future applications Scalability is one of the key challenges in MN innovation, often due to the fact that the majority of devices to date are made of metal. With a manufacturing process such as printing, as used for Radara®, costs can be kept low and volumes increased allowing for a greater range of MN’s to be produced, opening up varying therapeutic indications. The process employed by Innoture to develop Radara® is already being adapted to applications in pain management, dental anaesthesia, insulin delivery, glucose management, and as described here, cosmetic applications. Although not strictly required, the Innoture micro-channelling patch is currently undergoing medical device trials, with the aim of providing robust clinical data.
Declaration of interest None Figures 1-5, 7 © Benji Dhillon
Key points Report of key findings
from a 32 patient 8 week follow up split face study for a novel microneedling device to help improve fine lines and wrinkles in the crow’s feet lines area
3D imaging demonstrated an approximate 35% improvement in fine lines and wrinkles with the device and hyaluronic acid serum versus 24% for hyaluronic acid alone
This novel technology is a pain free mirconeedling modality to help maintain improvement in fine lines and wrinkles between more traditional botulinum toxin treatments
Figure 7 Average change in Rz-DIN values for 3D optical assessment of the depth of wrinkles from 1 week to 4
40 35 30 25 20 15
No MN
With MN
1
24 Week With a manufacturing process
such as printing, as used for Radara®, costs can be kept low and volumes
increased allowing for a greater range of MN’s to be produced, opening up varying therapeutic indications.
Figure 8 Average Rz-DIN values for 3D optical assessment of the depth of wrinkles from baseline to 8 weeks
170 160 150 140 130 120 110 100
Before 1
No MN With MN
2 Week References
1. Hartmann D et al. Complications associated with cutaneous aesthetic procedures. J Dtsch Dermatol Ges. 2015 Aug 13(8):778-86.
2. Bradley J et al. Fabrication of carbon nanotube-polymide composite hollow microneedles for transdermal drug delivery. Biomedical Microdevices 2014
3. Indermum S et al. Current advances in the fabrication of
microneedles for transdermal delivery. Journal of controlled release 2014.
4. Yan G et al. Enhacing DNA delivery into the skin with a motorized microneedle device. Eur J Pharm Sci. 2013
5. McCrudden MT et al. Microneedle applications in improving skin appearance. Exp Dermatol 2015 Aug; 24(8):561-6
6. El-Domyati M et al. Multiple microneedling sessions for minimally invasive facial rejuvenation: an objective assessment. Int J Dermatol. 2015 Jun 20. Epub ahead of print
7. Innoture Data on File. 2015.
8. Wang et al. In Vivo Stimulation of De Novo Collagen Production Caused by Cross-linked Hyaluronic Acid DermalFiller Injections in
Photodamaged Human Skin. Arch Dermatol. 2007;143(2):155-163.
9. Sivamani et al. Microneedles and transdermal applications. Expert Opinion Drug Deliv. 2007; 4:19–25.
10. Jung Lee H et al. Efficacy of microneedling plus human stem cell conditioned medium for skin rejuvenation: A randomized, controlled, blinded split face study. Ann Dermatol. 26(5). 2014
11. Bal et al. In vivo assessment of safety of microneedle arrays in human skin. Eur J Pharm Sci. 2008; 35:193–202.
12. Carruthers et al. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Crows Feet Lines: A Multicenter, Randomized, Controlled Trial, Dermatol Surg 2014;40:1181– 1190
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