Comparison of combination of imiquimod and glucantime with glucantime alone in treatment of acute anthroponotic cutaneous leishmaniasis

Completed

• Conditions: Anthroponotic cutaneous leishmaniasis; Leishmaniasis; Infections and Infestations

• Registration Number: ISRCTN77659407
• Lead Sponsor: World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients with anthroponotic cutaneous leishmaniasis caused by leishmania tropica
2. Aged 12 to 60 years
3. With less than 5 lesions each less than 5 cm in greatest diameter and duration less than 6 months

Exclusion Criteria

1. Pregnant or lactating women
2. Duration of lesions more than 6 months
3. Number of lesions more than 5
4. Lesions greater than 5 cm in their largest diameter
5. History of any full course of standard treatment (antimonials)
6. History of allergy to glucantime
7. Serious systemic illnesses (as judged by the physician)
8. Participation in any drug trials in the last 60 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The rate of clinical response (clinical cure, improvement, or failure) with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis<br>2. The rate of parasitological cure with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis<br>3. The rate of relapse with the two above mentioned treatment regimens 20 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis<br>4. The rate of adverse events with the two above mentioned treatment regimens for acute anthroponotic cutaneous leishmaniasis

Secondary Outcome Measures

Name	Time	Method
The rate of reduction in the size of lesions with the two above mentioned treatment regimens on 4 and 8 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis.