Inventi Rapid: Clinical Research

Inventi:prcr/44460/22

Standardization and Validation Study for Methods Used for Patch Testing

Standardization is the best approach to maximize compatibility, inter-operator/inter-observer variability, repeatability and verify the quality of the processes. The process of standardization can itself be standardized. This research article describes the standardization process for Patch Testing Studies. The objective of the study was to standardize and validate the patch test methods and controls (positive control and negative control) and irritation scoring by 24 Hours patch testing studies under complete occlusion or any patch testing studies. Safety was assessed throughout the study by monitoring of adverse events. The Single-center, evaluator-blinded clinical study of patch testing was conducted on ten healthy adult human subjects with varied skin types (Oily, Dry, Normal and Combination). Patch testing was done by applying the patches on the subjects' back (para-spinal region of back, between the scapula and waist) and worn the patches for 24 hours. The patches were then removed and the areas examined for signs of a reaction up to 168±2 hours. The results of negative and positive controls met the required criteria. Mean Irritation Score (MIS) was calculated. No complaints of adverse effects or worsening of skin conditions were reported on a single application of the product during and till the completion of the study. The study demonstrates various standardization methods used for patch testing. From this validation study, we have set a benchmark for patch testing which produces consistent, compatible, accurate, qualitative and reproducible results for patch testing studies....