A randomized controlled trial comparing the clinical efficacy and safety of Meglumine Antimoniate versus Miltefosine in the treatment of Cutaneous Leishmaniasis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251022011

Enrollment

Registered

2025-10-22

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

CUTANEOUS LEISHMANIASIS Meglumine Antimoniate Miltefosine Cutaneous leishmaniasis, meglumine antimoniate, miltefosine, efficacy, safety

Interventions

Patients were randomly allocated to either Group A or Group B, using the lottery method. Group A received meglumine antimoniate at a dose of 20 mg/kg.Follow-up assessments were conducted at 2 weeks, 4

Active Comparator Drug,Active Comparator Drug

Meglumine Antimoniate ,Miltefosine

Eligibility

Sex/Gender

All

Age

18 Years to 63 Years

Inclusion criteria

Inclusion criteria: 1)cutaneous leishmaniasis confirmed by either slit-skin smear and/or skin biopsy.

Exclusion criteria

Exclusion criteria: 1)Patients with liver disease, renal disease and cardiac disease, 2) hypersensitivity to meglumine antimoniate or miltefosine .

Design outcomes

Primary

Measure	Time frame
Clinical cure by week 8 8 weeks clinical response criterion	—

Secondary

Measure	Time frame
Drug safety was analyzed by assessing frequency and severity of adverse effects. 8 weeks clinical response criterion	—

Countries

Pakistan

Contacts

Public ContactMAIRA WAJAHAT

COMBINED MILITARY HOSPITAL QUETTA

MAIRAWAJAHAT47@GMAIL.COM03317690447

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026