Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000115235
Ethics application status
Approved
Date submitted
30/12/2008
Date registered
18/02/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
comparison between Intralesional injection of 2% zinc sulfate and intralesional glucantime in treatment of cutaneous leishmaniasis.
Scientific title
comparison between Intralesional injection of 2% zinc sulfate and intralesional glucantime in treatment of cutaneous leishmaniasis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
leishmaniasis 4164 0
Condition category
Condition code
Skin 4373 4373 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intraleisional injection of zinc sulfate 2% vial once every week until 10 weeks or until complete healing if happened earliear plus crotherapy at -196 degree celsius (liqiud nitrogen) once every other week until 10 weeks or until complete healing if happened earliear; it is performed as contact cryotherapy for 5-10 sec to the infected site
Intervention code [1] 3881 0
Treatment: Drugs
Comparator / control treatment
intralesional glucantime (435 mg of sb5+, active antimony) 15 mg/kg of active ingredient (antimony) once every week until 10 weeks or until complete healing if happened earliear plus crotherapy at -196 degree celsius (liqiud nitrogen) once every other week until 10 weeks or until complete healing if happened earliear ; it is performed as contact cryotherapy for 5-10 sec to the infected site
Control group
Active

Outcomes
Primary outcome [1] 5249 0
size of induration is measured with a transparent paper by an independed observer who was blind to the treat options
Timepoint [1] 5249 0
'size of induration' is measured 'every 2 weeks until 10 weeks ( end of treatment); 2weeks after end of treatment and 3 months after end of treatment
Secondary outcome [1] 8848 0
smear for leishmaniasis
Timepoint [1] 8848 0
smear is taken at the end of treatment; 2weeks and 3 months after the end of treatment

Eligibility
Key inclusion criteria
the patients with urban cutaneous leishmaniasis with the onset of lower than 3 months
Minimum age
5 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
taking any treatment of leishmaniasis within last month

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1503 0
Iran, Islamic Republic Of
State/province [1] 1503 0
Kerman

Funding & Sponsors
Funding source category [1] 4335 0
University
Name [1] 4335 0
Kerman medical university
Country [1] 4335 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Kerman medical university
Address
Kerman medical university,Kerman,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3905 0
Hospital
Name [1] 3905 0
Afzalipour hospital
Address [1] 3905 0
Afzalipour hospital,Kerman,Iran
Country [1] 3905 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6388 0
ethical committe of Kerman medical University
Ethics committee address [1] 6388 0
Ethics committee country [1] 6388 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6388 0
Approval date [1] 6388 0
Ethics approval number [1] 6388 0
k-25/35

Summary
Brief summary
Leishmaniasis is a parasitic disease that is endemic in developing countries such as our country. The incidence of leishmaniasis is more than 400,000 cases annually and the prevalence of all form of leishmaniasis is more than twelve millions.
Although cutaneous leishmaniasis (CL) is a self- healing disease , the duration of the disease is long and requeries several months and somtimes years before complete recovery , depending on the species of the infecting parasite . After recovery, a disfiguring scar can be left , which may destroy underlying structures like the nose or ear or cause psychological suffering of patients.
The first line drug for treatment of CL., according to WHO recommendation , is the pentavalent comounds such as meglomine antimoniate (Glucantime )
Other treatment for cutaneous leishmaniasis are intralesinal injection of meglomine antimonate, terbinafine , paramonycin ointment , and physical treatment including cryotherapy (cryosurgery) .In recent researches,zinc sulfate was studied in the treatment of this disease.But there are some contravesies.The aim of this study is the comparision of intralesional injection of zinc sulfate with intralesional glucantim in the treatment of cutaneou leishmaniasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35066 0
Address 35066 0
Country 35066 0
Phone 35066 0
Fax 35066 0
Email 35066 0
Contact person for public queries
Name 12413 0
Armita Shahesmaeili
Address 12413 0
Clinical research department, Afzalipour hospital,Kerman,Iran
Country 12413 0
Iran, Islamic Republic Of
Phone 12413 0
09133406291
Fax 12413 0
0098-0341-322-2270
Email 12413 0
[email protected]
Contact person for scientific queries
Name 3341 0
Saeedeh Farajzadeh
Address 3341 0
dermatilogy ward,Afzalipour hospital,Kerman,Iran
Country 3341 0
Iran, Islamic Republic Of
Phone 3341 0
09133414259
Fax 3341 0
0098-0341-322-2270
Email 3341 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison between intralesional injection of zinc sulfate 2 % solution and intralesional meglumine antimoniate in the treatment of acute old world dry type cutaneous leishmaniasis: a randomized double-blind clinical trial.2016https://dx.doi.org/10.1007/s12639-014-0609-1
N.B. These documents automatically identified may not have been verified by the study sponsor.