Intralesional sodium stibogluconate alone or its combination with either intramuscular sodium stibogluconate or oral ketoconazole in the treatment of localized cutaneous leishmaniasis: a comparative study.

BACKGROUND: Cutaneous leishmaniasis (CL) is a disease caused by leishmania species. Intralesional sodium stibogluconate (SSG) has been considered the first line therapy for localized cutaneous leishmaniasis. There is still a need for more effective and less time-consuming therapeutic methods for this condition.
OBJECTIVE: The aim of the present study was to investigate if the combination of intramuscular (IM) SSG or oral ketoconazole with intralesional (IL) SSG would be more effective than the intralesional SSG given alone in the treatment of localized cutaneous leishmaniasis. PATIENTS AND METHODS: Thirty patients with confirmed diagnosis of cutaneous leishmaniasis were included in the study. They were randomly assigned to three groups. The first group (10 patients with 12 lesions) was treated with intralesional SSG alone. The second group (10 patients with 15 lesions) was treated with the combination of intralesional SSG + intramuscular SSG. The third group (10 patients with 13 lesions) was treated with the combination of intralesional SSG and oral ketoconazole. A follow-up was performed every 4 weeks for a treatment period of 12 weeks, then monthly for a period of 6 months after the end of the treatment.
RESULTS: Complete cure occurred in 58.3% of lesions in group 1, while 93.3% and 92.3% of lesions were cured in group 2 and 3 respectively. The difference between group 1 and the other groups was statistically significant (P < 0.05).
CONCLUSION: Combined intramuscular SSG or oral ketoconazole with intralesional SSG is more effective than intralesional SSG alone for the treatment of CL. Oral ketoconazole is much easier and safer therapy than intramuscular SSG in combination with intralesional SSG in the treatment of localized cutaneous leishmaniasis.

RCT Entities:   Population Interventions Outcomes