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Trial registered on ANZCTR


Registration number
ACTRN12607000295448
Ethics application status
Approved
Date submitted
30/05/2007
Date registered
4/06/2007
Date last updated
4/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of cutaneous leishmaniasis with meglumine antimoniate and allopurinol.
Scientific title
A randomized controlled trial to evaluate the efficacy and safety of meglumine antimoniate (20mg) versus meglumine antimoniate (10 mg) plus allopurino (20 mg) in patients with cutaneous leishmaniasis to assess the efficacy in terms of healing time and to assess safety in terms of side effects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cutaneous leishmaniasis 1837 0
Condition category
Condition code
Skin 1931 1931 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Injection meglumine antimoniate 10 mg/kg/day plus tablet allopurinol 20 mg/kg/day (experimental drug) for a period of 28 days maximum.
Intervention code [1] 1787 0
Treatment: Drugs
Comparator / control treatment
Injection meglumine antimoniate 20 mg/kg/day (control) for a period of 28 days maximum.
Control group
Active

Outcomes
Primary outcome [1] 2744 0
Complete reepithelization
Timepoint [1] 2744 0
3 months after the beginning of the treatment.
Primary outcome [2] 2745 0
Absence of reactivation and affections of the mucous membrane during the 6 months of the study.
Timepoint [2] 2745 0
The lesion size and induration will be measured every week during the treatment phase (28 days), thereafter once monthly during the follow up phase to assess the increase/decrease in the size of lesions.
Secondary outcome [1] 4635 0
Incomplete reepithelization
Timepoint [1] 4635 0
Three months after the beginning of the treatment.
Secondary outcome [2] 4636 0
Increase in the size of the ulcer by more than 50% in relation to the last clinical evaluation.
Timepoint [2] 4636 0
Secondary outcome [3] 4637 0
Reactivation and/or affections of the mucous membranes during the 6 months of the study.
Timepoint [3] 4637 0
Study patients will be evaluated once weekly for ulcer size, induration and mucous membrane involvement, during the treatment period. In the follow up period patients will have monthly visits to record the parameters for 6 months.

Eligibility
Key inclusion criteria
2. Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring systemic therapy.283. Positive parasitological diagnosis for cutaneous leishmaniasis.4. Patients that voluntarily accept to participate in the study and sign the informed consent.5. Disposition to be admitted to hospital, if necessary, and to attend all the visits punctually (initial, treatment and follow up).6. Acceptation of not using any other treatment for cutaneous leishmaniasis while in the study.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women.2. Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of cutaneous leishmaniasis.3. Diffuse cutaneous leishmaniasis.4. Visceral leishmaniasis.5. Complete or incomplete treatment with antimony compounds in the last three months.6. Patients with history of hepatic, renal, or cardiovascular disease.7. Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2075 0
Hospital
Name [1] 2075 0
combined military hospital
Address [1] 2075 0
kharian cantonment
Country [1] 2075 0
Pakistan
Primary sponsor type
Individual
Name
Dr Amer Ejaz
Address
Country
Secondary sponsor category [1] 1880 0
Individual
Name [1] 1880 0
Dr SNR Qadir
Address [1] 1880 0
Country [1] 1880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3859 0
Research and ethics committee, Combined Military Hospital
Ethics committee address [1] 3859 0
Ethics committee country [1] 3859 0
Pakistan
Date submitted for ethics approval [1] 3859 0
Approval date [1] 3859 0
10/05/2007
Ethics approval number [1] 3859 0
RCT/001/2007

Summary
Brief summary
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries, that has shown an increasing incidence over the last many decades. For the last 60 years antimony compounds are considered the treatment of choice. Though their use is expensive, cumbersome, has many adverse effects and not effective in all patients, the search for a better alternative is still going on. Low dose antimony compounds in combination with several agents have shown promise of reducing adverse effects of antimony compounds without compromising efficacy. Allopurinol is one such agent which though promising lacks randomized, controlled trials to prove efficacy. The main objective of this study is to evaluate low dose sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study. After evaluating the inclusion/exclusion criteria patients will be randomized to receive either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During treatment patients will be admitted to hospital and monitored daily for the presence of adverse effects. Follow up period will last six months during which patients will visits the research centers for assessment of healing process at monthly intervals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27890 0
Address 27890 0
Country 27890 0
Phone 27890 0
Fax 27890 0
Email 27890 0
Contact person for public queries
Name 10976 0
Dr Amer Ejaz
Address 10976 0
Combined Military Hospital, Main boulevard, Kharian Cantonment
Country 10976 0
Pakistan
Phone 10976 0
00 92 300 928 7063
Fax 10976 0
Email 10976 0
amer_ejaz@yahoo.com
Contact person for scientific queries
Name 1904 0
Dr Amer Ejaz
Address 1904 0
Combined Military Hospital
Main boulevard
Kharian Cantonment
Country 1904 0
Pakistan
Phone 1904 0
00 92 300 928 7063
Fax 1904 0
Email 1904 0
amer_ejaz@yahoo.com

No data has been provided for results reporting
Summary results
Not applicable