Source: Cancer  |  Posted 5 years ago

By Jill Stein

RHODES, GREECE -- October 5, 2006 -- A regimen that combines a 4-week course of imiquimod 5% cream with a standard course of meglumine antimoniate did not provide any benefit compared with meglumine antimoniate alone in a study of patients with cutaneous leishmaniasis living in an endemic area of Leishmania tropica.

The results of the study were reported here on October 4[^]th[] at the 15[^]th[] Congress of the European Academy of Dermatology and Venereology (EADV).

Alireza Firooz, MD, director, Center for Research and Training in Skin Diseases and Leprosy, Tehran University, Tehran, Iran, presented results in 119 patients who had been randomised to 4 weeks of imiquimod plus meglumine antimoniate (20 mg of pentavalent antimony/kg/day for 2 weeks) or placebo plus meglumine antimoniate.

"Systemic pentavalent antimonials such as sodium stibogluconate and meglumine antimoniate have been used as the standard treatment for cutaneous leishmaniasis for about 75 years," Dr. Firooz said during the presentation. "However, they are only parenterally available, which is painful, toxic (especially for the heart and liver), and costly, which makes them unavailable in most endemic areas."

He also noted that the resistance of Leishmania to antimonials has been reported and, thus, several courses of treatment might be necessary.

Based on previous studies showing efficacy in cutaneous leishmaniasis, Dr. Firooz and colleagues conducted their trial to evaluate a 4-week imiquimod regimen in combination with megluminie antimoniate in patients with parasitologically proven cutaneous leishmaniasis based on positive smear and/or culture and were otherwise healthy.

The researchers defined clinical cure as complete re-epithelialisation of all lesions at the end of treatment. There were 59 patients in the imiquimod-treated group and of 60 patients in placebo-treated group.

At the 4-week evaluation, clinical cure rates were the same in both groups -- 1.7% in each ([]P[] = .990). At this time period, 5.1% of 59 imiquimod-treated patients and 3.3% of 60 placebo-treated patients were cured ([]P[] = .634).

The only adverse effects related to topical treatment were moderate pruritus and burning sensation in 6.7% of patients treated with imiquimod. Although none of the patients treated with placebo complained of these side effects, the difference between groups was not significant ([]P[] = .012).

Sixteen weeks after the end of treatment and among patients available for assessment, relapse was observed in 1 of 32 patients treated with imiquimod and 3 of 37 patients treated with placebo ([]P[] = .63).

Dr. Firooz said the results show that the addition of imiquimod to meglumine antimoniate confers no advantages for patients with cutaneous leishmaniasis.

The study was supported by the joint World Health Organization (WHO) Eastern Mediterranean Region, Division of Communicable Diseases, and the WHO Special Program for Research and Training in Tropical Diseases.

[Presentation title: Comparison of Combination of Imiquimod and Meglumine Antimoniate With Meglumine Antimoniate Alone in the Treatment of Acute Cutaneous Leishmaniasis: A Randomized Controlled, Single Blind Clinical Trial. Abstract P005.10]