post - kala - azar dermal leishmaniasis ( pkdl ) is a dermal manifestation of leishmania donovani infection and often follows resolution of clinical visceral leishmaniasis ( vl ) . however , it may also manifest without prior history of vl in a small minority of patients . pkdl is characterized by macular , papular , or nodular lesions or a mixture of them . it is quite common in sudan ( occurring in > 50% of patients with vl ) , where it may occur concurrently or follows immediately after an episode of vl and heals spontaneously in majority of patients , whereas in the indian subcontinent it occurs in 220% of patients , 6 months to several years after an episode of vl . in a recent trial the prevalence of confirmed pkdl cases was 4.4 per 10 000 individuals and 7.8 if probable cases were also considered . several treatment regimens have been recommended for the treatment of pkdl in india , for example , 120 days of parenteral sodium stibogluconate ( 20  mg / kg body weight )   or three courses of 20 daily infusions of amphotericin b with an interval of 20 days in between the courses . these inordinately long parenteral regimens invariably lead to either nonacceptance or poor compliance . in the last decade two new antileishmanial compounds , miltefosine and paromomycin , have been approved for the treatment of vl in india . there is a report about the efficacy of miltefosine at a higher dose 50  mg tid for 60 days ( with a need to extend to 90 days if required ) in small number of pkdl patients in bangladesh . of all the antileishmanial drugs , paromomycin is considerably cheaper and is produced in india . in this study the study was carried out at the kala - azar medical research center , muzaffarpur , the field site of the institute of medical sciences , banaras hindu university . patients with pkdl were enrolled between october 2007 and august 2009 and followed for one year after treatment . the study was approved by the institutional ethics committee , and written informed consent was taken from all enrolled patients and by the parents of patients of < 18 years of age . patients of both sexes , aged more than 10 years , with skin lesions of pkdl ( nodules , papules , plaques , or macules ) identified by a qualified and trained doctor at kala - azar medical research center , muzaffarpur , with or without history of an episode of vl in the past , were included in the study . taking into account the decreased slit - skin smear parasite and culture positivity in diagnosis of pkdl we did only pcr for making the diagnosis . the immune - chromatographic rk39 strip test was performed in serum of all the patients . only pcr and k39 positive confirmed cases were included in the study . patients with platelet count < 100000/mm , total leukocyte count ( tlc ) < 2500/mm and hemoglobin ( hb ) < 8.0  g/100  ml , hepatic enzymes > 3 times the upper limit of normal range , serum bilirubin > 2 times the upper limit of normal range , and serum creatinine or blood urea nitrogen ( bun ) above normal range were excluded from the study . patients with any noncompensated or uncontrolled condition , such as active tuberculosis , malignant disease , severe malaria , hiv , or other major infectious diseases , lactation , pregnancy , or inadequate contraception in females of childbearing potential for the treatment period , were also excluded from the study . once eligible for enrollment , patients were given daily paromomycin 11  mg / kg ( base ) intramuscularly for 45 days . clinical parameters like vital signs were assessed daily , and hematological and biochemical assessments were done on days 15 , 30 , and 45 of treatment . for monitoring the adverse events , except nephrotoxicity , common toxicity criteria of national cancer institute were used . if there was toxicity of grade 3 and above , the treatment was discontinued and the subject was removed from the study and offered rescue treatment . nephrotoxicity was defined as an increase in serum creatinine that was either double the baseline levels or more than 2.0  mg per deciliter [ 177  mol per liter ] . cure was defined as complete disappearance of skin lesion(s ) after treatment , as reported by the patient and assessed by the trained physician at 12-month followup . those patients who failed treatment in the form of no response and increase in number and size of lesion at 1-year followup and those patients in whom treatment was stopped due to adverse events were offered rescue treatment with three 20-day courses of amphotericin b in doses of 1  mg / kg given 20 days apart . comparison of means was done by using paired student 's t - test for paired data . a p value less than 0.05 ( < 0.05 ) was considered as statistically significant . thirty - one patients with pkdl were included in the study out of which three patients did not give a history of a prior episode of vl . the median duration of interval between treatment of vl and development of pkdl was two years . amongst the previously treated patients for vl , 22 patients were treated with sodium stibogluconate ( ssg ) , 3 patients with amphotericin b and miltefosine each , and 1 patient with paromomycin . among the various forms of skin lesions patients one had nodular lesion on face / chin with hypopigmented macular lesion over trunk , arms , and lower limb , and the other had hypopigmented macular and nodular lesions over the whole body . one patient presented with erythematous lesion over face while one patient presented with nodular and erythematous lesion on face with hypopigmented macular lesion over the whole body . pm was well tolerated by all patients without any significant derangement in hematological and biochemical parameter . 14 patients ( 45.2% ) complained of pain at injection site which was the most common side effect noted . posttreatment clinical , biochemical , and hematological parameters were similar to the baseline values except slight improvement in the platelet count ( table 1 ) . at one - year followup , out of 31 patients , 9 ( 37.5% ) were cured with complete disappearance of lesion while 15 ( 62.5% ) patients showed no improvement ; rather there was increase in lesion and appearance of nodular lesions in 11 patients . all the patients who improved were having macular lesions . among three patients who had nodular lesions , pm is very effective in the treatment of vl with a cure rate of ~95% . these results prompted us to use pm for the treatment of pkdl . since dose / duration of every antileishmanial drug in pkdl is 2 - 3 times that used for vl , we arbitrarily selected a regimen of pm for 45 days ( ~2 times of vl ) for the treatment of pkdl . though 45 days of pm treatment did not result in any noticeable adverse event except the expected injection site pain , the cure rate with this relatively better tolerated regimen of pm was unfortunately far from satisfactory . since these patients were admitted in the hospital for the entire duration of treatment , and pm injection was administered by nursing staff ; compliance was ensured . in india cure rates are 6492% with ssg in doses of 20  mg / kg per day for 120 days . ssg , being a toxic drug with high volume ( 1012  ml ) of intramuscular injections given in long regimen of 120 days , makes acceptance of this regimen very poor . similarly 60 injections of amphotericin b given over 100 days pose a real threat of nephrotoxicity . unfortunately , nearly every trial for pkdl consists of small number of patients with no randomization . clinical response may differ according to the type of lesions in pkdl ; nodules and papules disappear in 120 days , macules in 200 days . thus it becomes imperative to follow these patients for a sufficiently long duration to see the long term effects of treatment . though the cure rate was unacceptably low , it had noticeable activity and cured one - third of the patients . future studies using paromomycin with another antileishmanial drug like miltefosine could yield successful short duration regimen for the treatment of pkdl and should be tested . it is also important to know that the tolerance to the drug was excellent even though the drug was used for twice the duration of that used in vl . the unresponsiveness of pm in pkdl which is very effective for treatment of vl highlights that there is a lot to be still discovered about the mechanism and pattern of response of pm against different manifestations of leishmaniasis .