ABSTRACT
There is an absence of published or approved guidelines for the evaluation of drugs affecting hair growth. Only one hair growth stimulating agent so far has been approved in the US for male pattern baldness, which is a testimony to the difficulties and complexities we face in developing drugs affecting hair growth. To evaluate the systemic safety and local tolerance of the test drug, up to four times the usual dosage is applied for 14 days up to eight times daily to the scalps and chests of healthy bald male subjects in a randomized, double-blind trial. The chapter aims to determine efficacy and safety of the test drug in the treatment of male pattern baldness as compared with placebo. Phase I studies for the evaluation of drugs affecting hair growth should establish the systemic safety and local tolerance in healthy bald male volunteers.
