Penile application of dextrin sulphate gel (Emmelle)

Dextrin sulphate (DS) gel (Emmelle) is under development as a vaginal microbicide. Males who do not use condoms will be exposed to DS gel through sexual intercourse. A randomized, double-blind, placebo-controlled trial was conducted among 16 HIV-positive and 12 HIV-negative men to establish whether 4% DS gel has an acceptable safety profile. Men were asked to apply the gel to the penis once per day for 14 consecutive days and to leave it on for a minimum of 6 h. Results from laboratory evaluations, genital examinations, and adverse events reports showed that 4% DS gel administered topically to the penis was well tolerated when compared with placebo.