Comparison of Efficacy of Two Different Concentrations of Intralesional Amphotericin B in the Treatment of Cutaneous Leishmaniasis; A Randomized Controlled Trial

Abstract

Introduction: Cutaneous leishmaniasis is a vector borne disease caused by Leishmania major and Leishmania tropica. Bikaner is an endemic pocket for cutaneous leishmaniasis caused by Leishmania tropica.

Materials and methods: A prospective study was done to evaluate the efficacy of different concentrations of intralesional amphotericin B as a treatment modality for cutaneous leishmaniasis in Bikaner, Rajasthan, India from January 2016 to June 2017. Fifty patients were randomized into two groups, A and B. Twenty-five patients from group A, received intralesionl amphotericin B (2.5 mg/ml) 0.5 ml/cm², weekly for 8 weeks. Another group of 25 patients were treated by intralesional amphotericin B (5.0 mg/ml) weekly for same period. The cases were followed-up for response, side effects, and recurrence of disease.

Results: The results at the end of 8 weeks, showed complete response in 18 (72%) patients, partial response in 5 (20%) and 2 (8%) patients were non responders in group A. In group B, complete response was observed in 14 (56%), partial response in 7 (28%) patients and 4 (16%) patients did not show response. The difference was statistically insignificant (P > 0.05). No side effects were observed in both groups.

Conclusion: The difference between the efficacy of 5 mg/ml and 2.5 mg/ml concentrations of Amphotericin B injections was found to be statistically insignificant. So, weekly injections of amphotericin B looks promising, however, larger sample size is required to assess the efficacy of both concentrations in the treatment of cutaneous leishmaniasis.

Keywords: Amphotericin B; cutaneous leishmanisis; intralesional.

Figure 1

(a) Ulcerated indurated plaques, confirmed case of cutaneous leishmaniasis, treated with intra-lesional injections of 2.5mg/ml Amphotericin B, photograph taken at baseline. (b) Complete resolution of the lesion post treatment (with 8 weekly injections of 2.5 mg/ml Amphotericin B), with minimal residual scarring, photograph recorded 12 weeks after first session (Group A)

Figure 2

(a) Ulcerated plaque on the right elbow, confirmed case of cutaneous leishmaniasis, treated with intra-lesional injection of 5.0 mg/ml Amphotericin B, photograph taken at baseline. (b) Complete resolution of the lesion post treatment (with 8 weekly injections of 5 mg/ml Amphotericin B), with residual hypopigmentation and hyperpigmentation, photograph recorded 12 weeks after first session (Group B)