Clinical Study to Evaluate Safety and Efficacy of a Topical Hair Minimizing Lotion in Healthy Human Volunteers
Journal Title: Journal of Clinical Trials & Patenting - Year 2017, Vol 2, Issue 1
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 testmaterial 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***).
Authors and Affiliations
Kondhalkar Mrinmayee
Keywords
Related Articles
- EP ID EP245669
- DOI 10.13188/2573-3834.1000007
- Views 123
- Downloads 0
Clinical Study to Evaluate Safety and Efficacy of a Topical Hair Minimizing Lotion in Healthy Human Volunteers
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 option...
An Analysis on Transforming Developments in Electronic Hospital Management & Hospital Information Systems
Today’s global environment service delivery models have strongly impacted by the fast growth in Information & Communication Technology (ICT) and Internet power. E-Hospital Management systems provides the advantages of en...
Patent in Biomedicine
Intellectual property is a collective name for the ownership of the results of the human creative mind. Although it refers to intangible property, intellectual property entitles the holder of copyright or patent, tradema...
Magnesium: Important Role in Medicine & Oncology
Magnesium is an important mineral of our body involved in many human proteins and enzymes of our body. Its deficiency has significant consequences of the health and has been related to many diseases. In this paper I desc...
Patents and Information in Genes: Australia, Policy and the Distinction between DNA and cDNA
As in the United States, a prohibition on patenting isolated genetic sequences has now been recognized in Australia. On 7 October 2015, the High Court of Australia in D’Arcy v Myriad Genetics Inc., ruled unanimously that...