Comparative efficacy of intramuscular meglumine antimoniate and miltefosine in the management of cutaneous leishmaniasis

Comparative efficacy of intramuscular meglumine antimoniate and miltefosine in the management of cutaneous leishmaniasis in patients aged 18 - 60 years old.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000038392

Enrollment

126

Registered

2026-01-09

Start date

2025-10-01

Completion date

2025-11-01

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

to compare the efficacy of intramuscular meglumine antimonate and oral mitefosine in the management of cutaneous leishmaniasis based on the hypothesis that there is a difference in the efficacy of the two drugs mentioned.

Interventions

patients in group A will be treated with intramuscular meglumine antimoniate in the dosage of 15-20 mg/kg/day for 4 weeks. General physician will administer the injections. patients in group B will be treated with oral miltefosine 50mg tablet twice per day in 1st week and then three times per day for the next three weeks (for total of 4 weeks).

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

age range (18-60) years both male and female cases of cutaneous leishmaniasis as mentioned in the operational definition

Exclusion criteria

patients with liver and renal disease pregnant patients patients with hypersensitivity towards meglumine antimoniate or miltefosine

Outcome results