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 |
| Secondary identifying numbers | SGS 03/18; IRCT138706111166N1 |
- 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
Scientific
79 Taleghani Avenue
Tehran
14166
Iran
| Phone | +98 (0)21 897 8190 |
|---|---|
| firozali@sina.tums.ac.ir |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2004 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
14166
Iran
Sponsor information
World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
Research organisation
Research organisation
P.O.Box 7608
Nasr City
Cairo
11371
Egypt
| Website | http://www.emro.who.int/ |
|---|---|
"ROR" |
https://ror.org/01h4ywk72 |
Funders
Funder type
Research organisation
World Health Organisation - Eastern Mediterranean Regional Office (EMRO) (Egypt)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
