Na‐Bangchang 2016

Methods	Exploratory phase II, randomised, vehicle‐controlled, single‐centre (Ankober Health Center, North Shewa zone of Amhara region, Ethiopia) study Sample size calculation: not described
Participants	Leishamania type: not described Inclusion criteria: patients with localised cutaneous leishmaniasis (LCL) aged 18–65 years with a new, uncomplicated, localised, single lesion on the face or arms and positive parasite smear by microscopy Exclusion criteria: cutaneous leishmaniasis with secondary infection, concomitant diseases (mucocutaneous or visceral leishmaniasis), history of anti‐leishmanial treatment within the past 6 months, abnormality of biochemical and/or haematological laboratory tests, known hypersensitivity to any of the Shiunko components, or pregnancy (positive urine HCG test), breastfeeding, or possibility of becoming pregnant during the study N randomised: 40 were randomised to receive vehicle and Shiunko ointment (20 participants for each group) Withdrawals: 2 participants did not receive complete treatment, and 9 were not completely followed up. In the vehicle group, 2 and 5 cases did not have complete treatment and follow‐up, respectively. N assessed: 38 participants had complete treatment and 31, complete follow‐up. In the vehicle group, 18 and 15 cases had complete treatment and follow‐up, respectively.
Interventions	Group 1: the composition of Shiunko was as follows: 2.04 g shikon, 1.02 g tohki, 16.92 g sesame oil, and 6.76 g honeycomb wax Group 2: the vehicle contained 20 g wax Co‐interventions: cryotherapy was to be offered to all participants who were withdrawn or discontinued from the study for safety reasons Vehicle and Shiunko ointment applied on the lesion twice a day for 4 weeks Follow‐up: 16 weeks
Outcomes	Cure: complete cure was defined as complete wound closure and re‐epithelialisation without inflammation or infiltration and absence of parasite (amastigotes) within 12 weeks after the end of treatment. Partial response was defined as improvement of Leishmania signs (skin oedema, erythema, and/or hardening) and/or reduction in size but not total disappearance of the lesion and absence of parasite (amastigotes) within 12 weeks after the end of treatment. Treatment failure was defined as failure of the lesion size to decrease and/or lack of lesion sign improvement or re‐epithelialisation and/or presence of leishmanial amastigotes in the lesion 12 weeks after end of treatment (week 16) Adverse effects Clinical and parasitological assessments were performed before treatment, weekly for 4 weeks, and then 4, 8, and 12 weeks after the end of treatment
Notes	Study funding sources: the study was supported by the Institute of Tropical Medicine, Nagasaki University (Japan), ArmauerHansen Research Institute (Ethiopia), and Okusa Co., Ltd. (Japan). Possible conflicts of interest: there is no conflict of interest.