Condition category
Infections and Infestations
Date applied
22/01/2005
Date assigned
19/04/2005
Last edited
17/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.emro.who.int/

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

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17178983

Publication citations

  1. 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.

Additional files

Editorial Notes