Clinical Study to Evaluate Safety and Efficacy of a Topical Hair Minimizing Lotion in Healthy Human Volunteers

Abstract

Background: Management of unwanted hair growth arising due to hirsutism or hypertrichosis is a huge challenge. Prevalence rate of hirsutism due to endocrine disorders is very high with very few effective treatment options.Aims: Primary objective of this study was to evaluate safety of test material with repeated applications according to Draize and Use Test. Secondary objective of this study according to the Use Test was to evaluate hair growth inhibition potential of test material.Methods: Thirty four healthy volunteers were enrolled in an unicentric double blind, self-controlled clinical study to evaluate safety and efficacy of Romantaque according to Draize test and Use Test according to IS4011:1997/2009 guidelines for a period of one year. Efficacy was evaluated by Use Test according to IS4011:1997/2009 guidelines by phototrichogram. The data is analyzed using paired T test (two tailed).Results: All thirty four volunteers completed Draize Test and test material was found to be safe for use. Thirty volunteers were enrolled and completed the Use Test. None of the volunteers showed any adverse events during safety evaluations for Use Test. Efficacy evaluations for Use Test showed that the test group ("Romantaque Lotion") showed statistically significant hair growth inhibition. Also this test group consistently showed a dose response of reduction in number of hair at every time point as compared to pre-treatment levels. The differences between diameter of hair on Control and Test areas with respect to before and after treatment for all subjects was found to be statistically very significantly (p<0.0001***).This prompted us to assess and validate a new therapeutic FDA (MAH-India) approved topical Romantaque Lotion.