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ISRCTN
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ISRCTN77659407
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ClinicalTrials.gov identifier
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Public title
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Comparison of combination of imiquimod and glucantime with glucantime alone in treatment of acute anthroponotic cutaneous leishmaniasis
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Scientific title
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Acronym
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N/A
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Serial number at source
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SGS 03/18; IRCT138706111166N1
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Study hypothesis
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Four weeks treatment with topical imiquimod 5% cream applied 3 times/week will increase the efficacy of 2 weeks treatment with intramuscular injections of 60 mg/kg/day glucantime in the treatment of acute anthroponotic cutaneous leishmaniasis
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Iran
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Disease/condition/study domain
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Anthroponotic cutaneous leishmaniasis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2004
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Anticipated end date
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30/09/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120
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Interventions
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Group 1: Intramuscular glucantime (meglumine antimonate) 60 mg/kg/day for 14 days plus imiquimod 5% cream applied 3 times/week for 4 weeks
Group 2: Glucantime with the same dosage and duration plus placebo cream 3 times/week for 4 weeks
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Primary outcome measure(s)
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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
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
3. The rate of relapse with the two above mentioned treatment regimens 20 weeks after beginning treatment for acute anthroponotic cutaneous leishmaniasis
4. The rate of adverse events with the two above mentioned treatment regimens for acute anthroponotic cutaneous leishmaniasis
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Secondary outcome measure(s)
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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.
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Sources of funding
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World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17178983
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Contact name
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Dr
Alireza
Firooz
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Address
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79 Taleghani Avenue
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City/town
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Tehran
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Zip/Postcode
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14166
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Country
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Iran
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Tel
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+98 (0)21 897 8190
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Fax
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+98 (0)21 896 3804
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Email
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firozali@sina.tums.ac.ir
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Sponsor
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World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
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Address
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P.O.Box 7608
Nasr City
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City/town
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Cairo
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Zip/Postcode
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11371
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Country
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Egypt
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Sponsor website:
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http://www.emro.who.int/
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Date applied
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22/01/2005
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Last edited
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17/12/2008
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Date ISRCTN assigned
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19/04/2005
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