Adoption of inclusion- exclusion criteria based on the type of the study and treatment.

1Depending on available pre-clinical and reproductive toxicity data.2Age limit due to practical difficulties in measuring skin lesions in very small children.3Depending upon the Leishmania species and the type of treatment.4Due to practical difficulties in treating multiple lesions topically.5Due to practical difficulties in treating large lesions topically.6Topical treatment of lesions close to mucosae, eyes and ears is generally difficult and/or may pose safety hazard. Decision to include them in advanced phases of clinical evaluation depends on the risks associated with the specific delivery system or formulation used.7The decision to set a limit for the lesion age should take into consideration a) the Leishmania species –probability that lesions will self-heal within the study time; and b) the difficulty in accurately establishing the age of the lesion from interviewing the patient due to recall bias.8Depending on the risk of systemic toxicity based upon pre-clinical toxicity and clinical data available and the route of administration.