| MICRONEEDLING | PEER-REVIEW
treatment to either side of the face. Visia images were taken for all candidates up to 4 weeks. Eight patients, from each group were randomly selected for PRIMOS measurements up to 8 weeks. A dermatologist recruited by the Clinical Research
Organisation, Dermatest GmbH (Munster, Germany), reviewed each subject at baseline, 1 week, 2 weeks, and 4 weeks, for any signs of adverse reactions to the product or serum. The following were also evaluated at each visit: Tolerability Wrinkle assessment by subjects at 1, 2 and, 4 utilising a 10 point scale (10= very strong wrinkles; 1=almost no wrinkles)
Dermatologist wrinkle assessment at 1, 2, and, 4 weeks, with the same 10 point scale
3D objective assessment of the depth of wrinkles at 4 weeks utilising the PRIMOS imaging system. The PRIMOS optical 3D analysis system works by
projecting parallel stripes onto the surface of the skin. Differences in the height of the skin deflect the projected parallel stripes to represent a qualitative and quantitative measurement of the profile of the skin. For the purposes of this evaluation, the compact version of the PRIMOS device was used, which can record measurements of the profile of the skin without contact. One of the limitations of such devices is that the slightest movement of the skin can lead to erroneous results, and that the same area may not be measured. To mitigate this, the PRIMOS device and software allows for the same area to be identified and measured with a precision of one tenth of a pixel corresponding to a positioning of approximately 1m, as well as capturing multiple images to ensure any movement artifact is removed. The RzDIN value represents the greatest individual depth measurement of five adjacent individual troughs within the skin.
Results Subjective evaluation All subjects were followed up to 4 weeks, with 16 being followed up for another 4 for PRIMOS measurement. The average subject age was 48.7 years old. Eighteen (56%) of the subjects were smokers. No patients were lost to follow up for the duration of this study. Neither subjects nor investigators reported undesired skin reactions for any patient during the course of the study. The average value of subject self-assessment of
wrinkles at baseline was 4.4 (Radara®; range 2 to 7), and 4.5 (control; range 2 to 7). By 4 weeks the Radara® side demonstrated a 27.27% change from baseline, versus 26.7% for the control side (Table 1). A greater change from baseline represents a greater improvement in wrinkles. At baseline, the dermatologist evaluated average
wrinkle score was 4.6 (Radara®; range 2 to 7) and 4.6 (control; range 2 to 7). By week 4 weeks the Radara® side demonstrated a 32.61% change from baseline versus 28.26% for the control side (Table 2).
Figure 4
Distribution of microstructures on the Radara® patch
Figure 3
Microneedles printed onto a
flexible substrate
As part of the 8 week follow up of the 16 patients
randomly selected, in addition to PRIMOS evaluation, subjective wrinkle assessments were performed by the subjects and dermatologists. By 8 weeks, for those undergoing on-going PRIMOS evaluation, a 25% decrease from baseline for subjective wrinkle assessment for the Radara® side versus 19.5% (control) was observed. The dermatologist assessment demonstrated a 31% reduction for the Radara® group and a 25.6% decrease for the control group from baseline.
Primos results The average Rz-DIN value at baseline for the Radara® side was 163.1, which decreased to 130.2 at 1 week, 121.9 at 2 weeks, and 106.7 at 4 weeks, representing a
34.58% decrease from baseline (Figure 6). The value at baseline in the control area was 163.9, which after 1 week decreased to 133.3. At 2 weeks this decreased further to 129.6, and at 4 weeks was 125.3, representing a 23.55% decrease from baseline. The PRIMOS measurements for the randomly selected 16 patients up to 8 weeks, were made after a 4 week rest period with no patch or serum applied to either CFL area. At 8 weeks within the control arm, the change from baseline (163.9) to 8 weeks (149.9) represented a decrease of 8.54%, lower than that was observed from baseline to 4 weeks. For the Radara® side the change was somewhat greater
from baseline (163.1) to 8 weeks (133.0), representing a decrease of 18.45% (Figures 7, 8).
Figure 5 Split of patients and visit schedule 32 persons
GROUP ONE 16 persons LEFT SIDE
8 persons A candidate A1 8 persons Visia only
T0 All Visia T1
A candidate Primos
All Visia T2
A candidate Primos
GROUP TWO 16 persons RIGHT SIDE
8 persons A candidate A2 8 persons Visia only
All Visia A candidate Primos
T4 All Visia
A candidate Primos
T8 A candidate Visia
Primos
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