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

ISRCTN	ISRCTN77659407
DOI	https://doi.org/10.1186/ISRCTN77659407
Protocol serial number	SGS 03/18; IRCT138706111166N1
Sponsor	World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
Funder	World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)

Submission date: 22/01/2005
Registration date: 19/04/2005
Last edited: 17/12/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alireza Firooz
Scientific

79 Taleghani Avenue
Tehran
14166
Iran

Phone	+98 (0)21 897 8190
Email	firozali@sina.tums.ac.ir

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Imiquimod, glucantime
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	30/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	30/09/2005

Locations

Countries of recruitment

Iran

Study participating centre

79 Taleghani Avenue

Tehran
14166
Iran

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No