The EpiDerm™ Skin Irritation Test (EpiDerm™ SIT)

2017 ◽  
pp. 41-57
Author(s):  
Helena Kandarova ◽  
Manfred Liebsch
Keyword(s):  
Skin Irritation ◽  
Irritation Test ◽  
Skin Irritation Test

scholarly journals Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDerm™

2018 ◽  
Vol 50 ◽  
pp. 407-417 ◽  
Author(s):  
Helena Kandarova ◽  
Jamin A. Willoughby ◽  
Wim H. De Jong ◽  
Silvia Letasiova ◽  
Tatiana Milasova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

Development, optimization and standardization of an in vitro skin irritation test for medical devices using the reconstructed human tissue model epiderm

2015 ◽  
Vol 238 (2) ◽  
pp. S351-S352 ◽  
Author(s):  
H. Kandarova ◽  
J. Willoughby ◽  
W. de Jong ◽  
M. Bachelor ◽  
S. Letasiova ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Tissue ◽  
Skin Irritation ◽  
Tissue Model ◽  
Irritation Test ◽  
Skin Irritation Test

scholarly journals Formulation of tretinoin-loaded topical proniosomes for treatment of acne:in-vitrocharacterization, skin irritation test and comparative clinical study

Drug Delivery ◽  
2014 ◽  
Vol 22 (6) ◽  
pp. 731-739 ◽  
Author(s):  
Salwa Abdel Rahman ◽  
Nevine Shawky Abdelmalak ◽  
Alia Badawi ◽  
Tahany Elbayoumy ◽  
Nermeen Sabry ◽  
...  
Keyword(s):  
Clinical Study ◽  
Skin Irritation ◽  
Irritation Test ◽  
Comparative Clinical Study ◽  
Skin Irritation Test

Optimized Preparation of Capsaicin-Loaded Nanoparticles Gel by Box-Behnken Design

2014 ◽  
Vol 1061-1062 ◽  
pp. 359-368 ◽  
Author(s):  
Mei Ling Tang ◽  
Li Hua Chen ◽  
Dong Sheng Zhou ◽  
Wei Feng Zhu ◽  
Yong Mei Guan ◽  
...  
Keyword(s):  
Skin Permeation ◽  
Skin Irritation ◽  
Morphological Characteristics ◽  
Entrapment Efficiency ◽  
Box Behnken Design ◽  
Irritation Test ◽  
Predicted Values ◽  
Skin Irritation Test

A three-factor three-level Box-Behnken design(BBD) was employed to optimize capsaicin-loaded nanoparticles(Cap-NPs), and its properties in vitro and in vivo were evaluated. Particle size, morphological characteristics, entrapment efficiency of Cap-NPs were investigated respectively by Zetasizer, H7000 TEM and HPLC. Release, skin permeation and skin irritation test were investigated on mouse and rabbits. The predicted values of Cap-NPs were 94.50±6.33% for entrapment efficiency(EE) and 170.30±7.81 nm for particle mean diameter(PMD) under optimal conditions which were 346.33 bar (homogenization pressure, X1), 4.67 min(homogenization time, X2), and 15421.42 rpm (shear rate, X3). The in vitro permeation study showed that capsaicin permeability in NPs-gel was a 2.80-fold greater flux values than conventional ointment after 24 h. Cap-NPs-gel produce no observable skin irritation in rabbits within 72h. The optimized Cap-NPs-gel would be a good candidate for transdermal delivery.

Skin irritation testing in man for hazard assessment — evaluation of four patch systems

1995 ◽  
Vol 14 (9) ◽  
pp. 729-734 ◽  
Author(s):  
M. York ◽  
DA Basketter ◽  
JA Cuthbert ◽  
L. Neilson
Keyword(s):  
Skin Irritation ◽  
Research Programme ◽  
Predictive Testing ◽  
Hazard Identification ◽  
Hazard Evaluation ◽  
Rabbit Skin ◽  
Range Finding ◽  
Irritation Test ◽  
Patch Removal ◽  
Skin Irritation Test

1 The limitations of the Draize rabbit skin irritation test for hazard evaluation for man are widely documented. Nevertheless it remains the prescribed method for deter mining acute skin irritation hazard. 2 While the use of human testing for risk assessment of irritants is well established, the use of predictive testing in man for hazard identification has not been explored widely, and this is the object of the research programme. 3 The experiment described in this report evaluates the sensitivity of four patch testing systems (Finn chamber, Hill Top patch, Van der Bend chamber, and Webril patch) using a total of six irritant substances. 4 Following preliminary range-finding experiments, test materials were applied to the upper outer arm for up to 4 h. Assessments were performed immediately after patch removal and at 1, 24, 48 and 72 h. 5 Webril and Hill Top patches generated the greatest lev els of response, although responses with Finn and Van der Bend were observed. Hill Top patches are recom mended for future development work. 6 The use of very small preliminary panels to predict the effects in larger panels using different volunteers was only of limited value as each volunteer was found to have different irritant thresholds.

In vitro skin irritation test: Increasing the sensitivity of the EpiDerm skin irritation protocol evaluated in the ECVAM skin irritation validation study

2007 ◽  
Vol 172 ◽  
pp. S81 ◽  
Author(s):  
Helena Kandárová ◽  
Patrick Hayden ◽  
Erin Spiller ◽  
Mitch Klausner ◽  
Joseph Kubilus ◽  
...  
Keyword(s):  
Validation Study ◽  
Skin Irritation ◽  
Irritation Test ◽  
Skin Irritation Test
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