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Efficacy of Topical Liposomal Glucantime or Paromomycin in Combination With Systemic Glucantime for the Treatment of AC

Early Phase 1
Conditions
Protozoal diseases.
Cutaneous Leishmaniasis
Registration Number
IRCT138809051475N4
Lead Sponsor
Mashhad University of Medical sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

1.Male or female aged between 12 to 60 years.
2.Parasitologically proven CL due to L. tropica.
3.History of failure to at least one full course of systemic Glucantime.
4.In general good health based on history and physical examination.
5.Number of lesion at most 4.
6.Lesion size less than 3 cm.
7.Signed informed consent voluntarily and knowingly**.
** Guardian’s signature for volunteer less than 18 years old.
Exclusion criteria:
1.Pregnant or lactating women and those who are planning to be pregnant in next 60 days.
2.Use of other types of treatment for CL.
3.Involvement in any other drug or vaccine trial during the study period.
4.Known heart, kidney, liver diseases based on history and physical exam.
5.Abnormal ECG

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Complete cure equal to Complete Re-epithelization of all lesions. Timepoint: weekly. Method of measurement: Taking digital pictures.
Secondary Outcome Measures
NameTimeMethod
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