Contact information
Type
Scientific
Primary contact
Dr Alireza Firooz
ORCID ID
Contact details
79 Taleghani Avenue
Tehran
14166
Iran
+98 (0)21 897 8190
firozali@sina.tums.ac.ir
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SGS 03/18; IRCT138706111166N1
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anthroponotic cutaneous leishmaniasis
Intervention
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
Intervention type
Drug
Phase
Not Specified
Drug names
Imiquimod, glucantime
Primary outcome measure
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
Secondary outcome measures
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.
Overall trial start date
01/07/2004
Overall trial end date
30/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/07/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
Iran
Trial participating centre
79 Taleghani Avenue
Tehran
14166
Iran
Sponsor information
Organisation
World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
Sponsor details
P.O.Box 7608
Nasr City
Cairo
11371
Egypt
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17178983
Publication citations
-
Results
Firooz A, Khamesipour A, Ghoorchi MH, Nassiri-Kashani M, Eskandari SE, Khatami A, Hooshmand B, Gorouhi F, Rashighi-Firoozabadi M, Dowlati Y, Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial., Arch Dermatol, 2006, 142, 12, 1575-1579, doi: 10.1001/archderm.142.12.1575.