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Fairfield, NJ, United States

Caswell M.,Consumer Product Testing Company
Journal of cosmetic science | Year: 2012

Like water resistance in sunscreens, sand resistance in sunscreens is the ability of the sunscreen to retain its effectiveness while undergoing sand treatment. The influence of the type of sand on the sand resistance of sunscreens has not been described. The sand resistance of a control standard sunscreen, P2, and data on three grades of Quickrete commercial grade sand, #1961, #1962, and #1152, are described. These sands represent a fine sand, a medium sand, and an all-purpose sand. Using the methodology described in the 2007 proposed amendment of the Final Monograph (1) with one exception, we obtained an SPF of 16.5 (1.6) for the control standard, compared to the expected SPF of 16.3 (3.4). After a five-minute treatment of sand #1961, #1962, or #1151, the SPF of the control standard was 18.3 (1.6), 18.4 (2.0), and 17.5 (2.2), respectively. Thus, all three sands exhibited a similar sand-resistance response. Thus, there was no significant difference in the average SPF with and without sand. The medium grade sand, Quickrete commercial grade #1962, was preferred for sand-resistance testing because the fine sand was difficult to remove from the subject's backs and the coarse sand was unpleasant to the subjects. Source


Garzarella K.,Consumer Product Testing Company
Journal of cosmetic science | Year: 2013

Regulatory agencies throughout the world have developed exclusive methodologies for assessing and classifying sunscreen product efficacy in their respective markets. Three prevalent methods, the Food and Drug Administration-Final Monograph (FDA-FM) method, the Australia/New Zealand (Aus/NZ) method, and the COLIPA International (International) method, contain procedural and statistical dissimilarities with undefined significance. The objective of our clinical trials was to evaluate the influence of these disparities on sun protection factor (SPF) values. Our clinical trials evaluated the SPF of 59 test materials, using two or all three of the aforementioned methods in simultaneous trials, providing two or three SPF values for each formulation. A total of 135 trials were conducted. The consequent mean SPF values generated per trial were used to compare methods in a correlation and variance analysis. The correlation coefficients for each method pair, International vs. FDA-FM, Aus/NZ vs. FDA-FM, and International vs. Aus/NZ, were each ≥0.94. The difference in least square mean SPF for each method pair was 0.12, 0.62, and 0.81, respectively. Our juxtaposition of the mean SPFs produced by these methods clearly illustrate that any disparities between average SPF values produced by these methods are not clinically or statistically significant and that using one method should be sufficient for SPF labeling in all three respective markets. Source


Chang A.,John Muir Physician Network Clinical Research Center | Frank J.,Consumer Product Testing Company | Knaebel J.,Bayer AG | Fullam J.,Bayer AG | And 2 more authors.
Journal of Diabetes Science and Technology | Year: 2010

Background: Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C. Methods: Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material ± DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey. Results: A total of 110 subjects with (n = 93) and without (n = 17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results (R2 = 0.93 for both). The average within-subject coefficient of variation was 4.57% (n = 74). The FTF rates with and without instructional DVD were 11.3% (n = 56) and 39.6% (n = 54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were "very" to "extremely" likely (93.5%) to discuss their home A1C results with their HCP. Conclusions: Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately. © Diabetes Technology Society. Source


Caswell M.,Consumer Product Testing Company | Frank J.,Consumer Product Testing Company | Viggiani M.T.,Bayer AG | Pardo S.,Bayer AG | And 3 more authors.
Diabetes Technology and Therapeutics | Year: 2015

Background: The accuracy of the Contour® Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies. Materials and Methods: In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared. Results: In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use. Conclusions: The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals. © Mary Ann Liebert, Inc. 2015. Source


Caswell M.,Consumer Product Testing Company | Wood C.,Consumer Product Testing Company | Maly E.,Consumer Product Testing Company
Journal of Cosmetic Science | Year: 2011

To determine the water resistance of a sunscreen, the COLIPA method requires the determination of two minimal erythema doses (MEDs): a static MED (MEDUS) and a wet MED (MEDUW)(I). The MED US is used in calculating the static SPF; the MEDUW is used in calculating the SPF after water immersion. Herein, we report that in the 107 subjects examined, the mean MEDUS (21.0±0.55 mJ) is not different from the mean MEDUW (21.0±0.6l mJ). This shows that water immersion does not alter the minimal erythema dose and strongly suggests that the determination of two MEDs is unnecessary and that one should be eliminated. Eliminating one of the two MED determinations would increase the benefit/risk ratio of the COLIPA sunscreen water-resistance efficacy testing without harm to efficacy. Source

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