Clinical Research Detail Title Of Study Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL). Disease Condition n India 5 to 10 % of patients with visceral leishmaniasis (VL) go on to develop post kala azar dermal leishmaniasis (PKDL, three months to three years after VL has been apparently cured. Indian PKDL can occur concurrently with VL also as reported in a few patients.Clinical features consist of hypopigmented macules and/or diffuse infiltration, papules, nodules, or plaques.The current treatment recommendations for treatment include either sodium stibogluconate 20 mg/kg intramusclualry (10 ml for a 50 kg person) for 120 days or amphotericin B deoxycholate infusions 20 infusions for three such courses over an eighty day period. Such prolonged, painful and toxic regimen results in frequent non-compliance, which is almost a rule. Thus, treating PKDL has been an exceptionally difficult task. Unless there are compelling situation like lesions over face preventing marriage, patients tend to avoid treatment. Patients with PKDL represent an important but largely neglected reservoir of infection that perpetuates anthroponotic Leishmania donovani disease in India, and focal VL outbreaks have been linked to an index case of PKDL. Ambisome is a liposomal formulation of amphotericin B, associated with significantly lower renal toxicity than amphotericin B, which is dose-limiting. It is an effective and well tolerated drug licensed for treatment of VL in India. AmBisome is the safest and probably the most efficacious of all anti-leishmanial drugs currently available. (Bern et al, 2006).A drug which is safe and effective after parentral administration for shorter duration is needed for the treatment of patients with post kala azar dermal leishmaniasis. Such drug would facilitate treatment, increase compliance, and lower cost of treatment. The proposed trial objectives are: Primary objective: ? To assess liposomal amphotericin B regimens 2.5 mg/kg/bw for 20 consecutive days duration for their curative potential in PKDL (parameter: rate of patients with macular/nodular and papular lesions who achieve negative parasitology and clinical severity score of zero 12 months after end of treatment). Secondary objectives: ? To characterize the safety of liposomal amphotericin B when used for periods up to 20 days in three courses at the interval of 15 to 30 days. ? To assess the rates of initial response in relation to duration of treatment. ? To assess the rates of relapse after initial response ? To assess the clinical response of facial erythema and mucosal lesions Total number of patients planned 50. Duration of study: two years. Phase of Trial N/A Discipline Pharmacology Start date of Trial 2/18/2010 Closing Date of Trial 2/18/2012 If you are a doctor interested in clinical research then upload your profile. Click here If you are a hospital interested in clinical research then upload your profile. Click here If you are a patient interested to know more about this clinical trial mail us at:   [email protected]