PEER-REVIEW | MICRONEEDLING |
Figure 1 Image of microneedles with a height of 500m
Methods and materials As this product is not classified as a medical device, Ethics Approval was not required for the conduct of this prospective observational split face study. The materials used to create the patches are all FDA-approved for human use in clinical applications and currently ‘in use’ within medical device components. Due to its exploratory nature no power calculations
were performed for this study. A sample size of 32 was selected to ensure that with an approximate 20% drop out rate, at least 16 patients would be available for PRIMOS evaluation. Baseline demographic data such as age and smoking status were recorded, however Fitzpatrick skin type was not. Thirty-two adult females between the ages of 35–55
The substrate is a polyurethane foam of 400m
thickness, which is commonly used in skin contact medical devices such as sensors for ECG leads, and is adhesive with USP Class VI and ISO 10993 biocompatibility standards. Radara® has been designed for
single use application in conjunction with a hyaluronic acid (HA) serum. It can conform and adhere to the skin by itself and requires an application period of 5 minutes per day for 1 month. Hyaluronic acid (HA) was
Although current HA based products such as
dermal fillers are primarily used to volumise and help
chosen as the molecule of choice to improve CFL wrinkles, given its volumising as well as hygroscopic characteristics. Although current HA based products such as dermal fillers are primarily used to volumise and help create ‘lift’ in planes deep to the dermis there is evidence of its ability to improve the superficial appearance of the skin. Wang et al8
described
how cross-linked HA when injected into the middle and lower dermis, stimulated fibroblasts, and increased the levels of collagen type 1 and connective tissue growth factors compared to controls. The purpose of this article is to report on the findings
from an observational study assessing the impact of Radara® and the microchannels it forms, on the HA’s effects on skin quality and wrinkles in the CFL area, versus HA alone without Radara®.
Figure 2 Optical Coherence Tomography image of microneedles penetrating the skin
create ‘lift’ in planes deep to the dermis there is evidence of its ability to improve the superficial appearance of the skin.
years old were enrolled into the study, and equally randomised into one of two groups; either to have the patch applied to the right or left CFL area (Figure 5). Exclusion criteria included the following: Presence of erythema, infection, scaling or dryness within the test area as determined by an accredited dermatologist
Application of pharmaceutical products and skin care products with active ingredients 7–10 days before testing or washout period
History of allergic reaction or side effects after the use of cosmetic products
Sunbathing or sun bed use during the study period Known cancer Pregnancy or lactation. Males were not included in this study, as they were not
determined to be the primary intended user. After receiving informed consent, all subjects received
a 4 week supply of single use only Radara® patches as well as two bottles of HA serum, which only allowed for a single unit dosage of 0.2 mls per pump. Each bottle contained enough HA for a daily treatment for the duration of the 4 weeks. All subjects were trained by dermatologists to self apply Radara® to the designated CFL area (right or left) once per day, followed by topical application of a single dose of HA serum to the patch for 5 minutes only, followed by disposal. Training was also provided on the application of HA serum only, without the patch to the contralateral side for 5 minutes before cleaning it off the skin. Following 4 weeks of daily applications, a 4-week washout period ensued with no
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October 2015 |
prime-journal.com
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