Evaluating the Efficacy of Combined Intralesional Sodium Stibogluconate Plus Topical Imiquimod on Healing and Risk of Scarring of Cutaneous Leishmaniasis: A Case-Control Study

Background: A combination treatment of cutaneous leishmaniasis (CL) that hastens the healing and reduces the chance of scarring, especially in aesthetically receptive sites, is required. Objectives: To evaluate if a combination of intralesional sodium stibogluconate (SSG) injection and topical imiquimod 5% cream (IMI) accelerates healing and improves the quality of scars from CL. Patients and Methods: A prospective, placebo-controlled, randomized clinical trial was conducted at Basrah Teaching Hospital, Basrah, southern Iraq from 2017 to 2019 on a cohort of patients with CL. Eligible patients were injected intralesionally with sodium stibogluconate (SSG) weekly for six weeks and randomized to receive either topical imiquimod 5% cream (IMI group) or topical emollient cream (placebo group). The healing rate and scar quality were assessed at week six. Results: One hundred twenty-one patients completed the trial (66 [55%] males, mean age SD: 34.1 years). The clinical healing rate was significantly higher in the IMI group than in the placebo group (94% versus 74%, p <0.05). A high rate of scars was noticed in both groups (66.6% in the IMI group and 91.2% in the placebo group). However, superficial non-atrophic scars were more frequent in the IMI group (40% versus 26%), while deep atrophic scars were more evident in the placebo group than in the IMI group (65.2% versus 26.6%, p<0.05). Conclusions: Combined intralesional SSG plus topical imiquimod was beneficial in accelerating CL healing and improving scar quality, and should be considered when CL is located in aesthetically sensitive areas.