A NOVEL EXPLORATORY APPROACH OF VALIDATION AND STANDARDIZATION FOR TEST METHODS AND EVALUATORS TO CONDUCT SAFETY AND EFFICACY CLINICAL TESTING OF HAIR GROWTH PRODUCTS

Abstract

Background: There is an explosion of cosmeceuticals and hair products in the modern world. Despite the high prevalence and impact on quality of life, there are no gold standards for qualitative and quantitative methods are established available for standardization and validation purposes. This study aimed to standardize Aims: the hair tests and methodology for all researchers. It demonstrates the standardize and validate the methods (Non-invasive and SemiInvasive methods) such as the 60-second hair combing test, pull test, pluck test, trichogram review, phototrichogram test, standardizing the hair growth rate measurement, scoring of hair quality general appearance and scalp condition - evaluations techniques and procedural steps. This study standardized and validated different variabl Methods: es and all the above-mentioned techniques and procedural steps which were assessed by phototrichogram and equipment such as CASLite Nova on healthy adult human subjects. The positive correlation was shown between th Results: e Dermatologist and the Dermatologist's Trained Evaluators' and these correlations were highly significant for all three evaluators. During phototrichogram evaluations, all pairs p-values were found >0.05 (except pairs 15 and 17), showing that there was no statistically significant difference in the mean value of the evaluator. All the p-value for the pull test of independence is not significant for pull test results and showed that all three evaluators (evaluator#1, 2, 3) values are dependent and related to each other's showing a correlation among them. For the pluck test, the results of the evaluators' readings the Pearson correlation is near to “+1 or +0.5” for Evaluators #1 and 2 indicating that there was a positive correlation between the Dermatologist and Evaluators #1 and 2. We established the standards to perfo Conclusions: rm test methods with the least minimal variability for phototrichogram, microscopical evaluation, and statistically significant correlations between the evaluator for the above-mentioned techniques, and statistically significant correlation between the dermatologist and evaluators to confirm that the designated evaluator is Dermatologist Trained and Validated to perform the methods efficacy claims substantiation for Hair Growth products. This standardization will assist the post graduate students as well as practitioners in the field of research and dermatology.