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.

Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review

“…However, some useful observations maybe drawn from the experiences gathered thus far. It can be highlighted, among others, the observation of the lack of evidence for association between effect and number of applications of the ointment formulation addressed by Lo ´pez at al., (2018) [39], in the same way that a PLOS NEGLECTED TROPICAL DISEASES higher concentration of the AmB solution infiltrated by Goswami et al, (2019) [38] did not affect the efficacy of the treatment.…”

Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review

“…However, some useful observations maybe drawn from the experiences gathered thus far. It can be highlighted, among others, the observation of the lack of evidence for association between effect and number of applications of the ointment formulation addressed by Lo ´pez at al., (2018) [39], in the same way that a PLOS NEGLECTED TROPICAL DISEASES higher concentration of the AmB solution infiltrated by Goswami et al, (2019) [38] did not affect the efficacy of the treatment.…”

Invasive Fungal Sinusitis and Its Orbital Morbidity in Pediatric Population: A Strategic Treatment Algorithm and Outcomes

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22 Fungal skull base osteomyelitis is another worrying presentation of fungal sinusitis. This complication typically requires an extended period to stabilize pathologically, necessitating prolonged antifungal therapy.…”

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22…”

Chromoblastomycosis is curable with DAT therapy (debulking, intralesional amphotericin B, oral terbinafine); case series of 16 patients

“…Weekly intralesional AMB for 8 weeks as monotherapy had been tried in 5 mg/mL and 2.5 mg/mL concentrations showing 78% and 56% complete response respectively. [ 1 ] Physical interventions such as surgical excision and cryotherapy were curative on smaller lesions. A combination of intralesional AMB and oral terbinafine 500 mg daily was proven curative against melanized fungi in vitro and in vivo showing shorter duration of therapy without side effects.…”

“…However, higher concentrations of AMB may be used safely as proven by Goswami et al . [ 1 ] and may show faster response. Electrocautery was the preferred debulking method as it was easy to perform in an outpatient clinic, cheaper, did not need prior patient preparations or postoperative care, and successfully removed even bigger nodules and plaques.…”

Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review

“…However, some useful observations maybe drawn from the experiences gathered thus far. It can be highlighted, among others, the observation of the lack of evidence for association between effect and number of applications of the ointment formulation addressed by Lo ´pez at al., (2018) [39], in the same way that a PLOS NEGLECTED TROPICAL DISEASES higher concentration of the AmB solution infiltrated by Goswami et al, (2019) [38] did not affect the efficacy of the treatment.…”

Invasive Fungal Sinusitis and Its Orbital Morbidity in Pediatric Population: A Strategic Treatment Algorithm and Outcomes

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22 Fungal skull base osteomyelitis is another worrying presentation of fungal sinusitis. This complication typically requires an extended period to stabilize pathologically, necessitating prolonged antifungal therapy.…”

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22…”

Chromoblastomycosis is curable with DAT therapy (debulking, intralesional amphotericin B, oral terbinafine); case series of 16 patients

“…Weekly intralesional AMB for 8 weeks as monotherapy had been tried in 5 mg/mL and 2.5 mg/mL concentrations showing 78% and 56% complete response respectively. [ 1 ] Physical interventions such as surgical excision and cryotherapy were curative on smaller lesions. A combination of intralesional AMB and oral terbinafine 500 mg daily was proven curative against melanized fungi in vitro and in vivo showing shorter duration of therapy without side effects.…”

“…However, higher concentrations of AMB may be used safely as proven by Goswami et al . [ 1 ] and may show faster response. Electrocautery was the preferred debulking method as it was easy to perform in an outpatient clinic, cheaper, did not need prior patient preparations or postoperative care, and successfully removed even bigger nodules and plaques.…”

Local amphotericin B therapy for Cutaneous Leishmaniasis: A systematic review

“…However, some useful observations maybe drawn from the experiences gathered thus far. It can be highlighted, among others, the observation of the lack of evidence for association between effect and number of applications of the ointment formulation addressed by Lo ´pez at al., (2018) [39], in the same way that a PLOS NEGLECTED TROPICAL DISEASES higher concentration of the AmB solution infiltrated by Goswami et al, (2019) [38] did not affect the efficacy of the treatment.…”

Invasive Fungal Sinusitis and Its Orbital Morbidity in Pediatric Population: A Strategic Treatment Algorithm and Outcomes

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22 Fungal skull base osteomyelitis is another worrying presentation of fungal sinusitis. This complication typically requires an extended period to stabilize pathologically, necessitating prolonged antifungal therapy.…”

“…21 In a randomized controlled trial by Goswami et al, comparing the efficacy of 2 concentrations of AMB (2.5 vs. 5 mg/mL), the difference in efficacy between the 2 concentrations was statistically insignificant. 22…”

Chromoblastomycosis is curable with DAT therapy (debulking, intralesional amphotericin B, oral terbinafine); case series of 16 patients

“…Weekly intralesional AMB for 8 weeks as monotherapy had been tried in 5 mg/mL and 2.5 mg/mL concentrations showing 78% and 56% complete response respectively. [ 1 ] Physical interventions such as surgical excision and cryotherapy were curative on smaller lesions. A combination of intralesional AMB and oral terbinafine 500 mg daily was proven curative against melanized fungi in vitro and in vivo showing shorter duration of therapy without side effects.…”

“…However, higher concentrations of AMB may be used safely as proven by Goswami et al . [ 1 ] and may show faster response. Electrocautery was the preferred debulking method as it was easy to perform in an outpatient clinic, cheaper, did not need prior patient preparations or postoperative care, and successfully removed even bigger nodules and plaques.…”