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Randomized trial of local injections for cutaneousleishmaniasis caused by L. tropica

Efficacy of intra-lesional injections of meglumine antimoniate once a week vs. twice a week in the treatment of cutaneous leishmaniasis caused by L. tropica in Iran

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081130001475N13
Enrollment
180
Registered
2019-12-30
Start date
2017-09-23
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

Leishmania. Cutaneous leishmaniasis

Interventions

Intervention 1: Intervention group: Once injection per week. Intervention 2: Intervention group: Twice a week.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 70 Years

Inclusion criteria

Inclusion criteria: 80-70 year old patients with clinically suspected CL lesion(s) with Parasitological proven (smear and/or culture) CL patients caused by L. tropica were recruited into the study if they met other eligibility criteria. Polymers chain reaction (PCR) was performed on every sample to assure that the lesion was caused by L. tropica. Other inclusion criteria were age 8-70 years, willingness to participate in the trial, and sign an informed consent and an oral assent from the children.

Exclusion criteria

Exclusion criteria: Patients with lesion(s) duration more than 6 months, more than 4 lesions, ulcer size more than 3 cm, lesions on the face or close to a vital organ, pregnant and nursing patients, those with a history of previous systemic or IL treatment with MA or those with an acute or chronic disease that could affect the course of CL or treatment with IL-MA injections were excluded.

Design outcomes

Primary

MeasureTime frame
Primary outcome of the study was complete cure defined as complete re-epithelialization of the lesion with no induration. Timepoint: Before the intervention and every week. Method of measurement: Measurement of the lesion.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Khamesipour

Tehran University of Medical Sciences

ali.khamesipour@gmail.com+98 21 8897 2221

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026