A RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN TUNISIA TREATING CUTANEOUS LEISHMANIASIS WITH PAROMOMYCIN OINTMENT

A randomized, placebo-controlled, double-blind trial was carried out i n 1992 in central Tunisia to assess the tolerability and efficacy of p aromomycin ointment against zoonotic cutaneous leishmaniasis caused by Leishmania major. One hundred fifteen patients, 2-60 years of age, wi th a single lesion of parasitologically confirmed cutaneous leishmania sis, were included in the trial. The ointment was applied twice a day from day 1 through day 14. Clinical and parasitologic evaluations of l esions were done at days 0, 15, 45, and 105. Fifty-seven patients were allocated the treatment and 58 the placebo. Based on local toxicity a nd laboratory evaluation, there was no difference in tolerability betw een the two groups. Parasitologic evaluation at day 15 showed that 74. 5% of the treated group had negative smears compared with 56.4% among controls (P = 0.06). This difference was no longer apparent at days 45 and 105. Clinical evaluation at days 15, 45, and 105 did not indicate any difference between the two groups. The clinical evaluation at day 15 was a good predictor of the final prognosis of the lesion in the t wo groups when analyzed separately, suggesting no clinical relapse in either group. These findings suggest that paromomycin ointment should not be used in the present formulation as a treatment for zoonotic cut aneous leishmaniasis in Tunisia.