Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000113257
Ethics application status
Approved
Date submitted
31/12/2008
Date registered
18/02/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The comparison between topical terbinafine and placebo in the treatment of cutaneous leishmaniasis
Scientific title
The comparison between topical terbinafine and placebo in the treatment of cutaneous leishmaniasis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cutaneou leishmaniasis 4166 0
Condition category
Condition code
Skin 4375 4375 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical terbinafine 2% cream twice daily until 10 weeks was applied on the cutaneous leishmaniasis lesions
+ intralesional injection of glucantime (435 mg of sb5+, active antimony) once per week until 10 weeks
Intervention code [1] 3884 0
Treatment: Drugs
Comparator / control treatment
placebo ( vaseline cream Mahan) twice daily until 10 weeks was applied on the cutaneous leishmaniasis lesions
+ intralesional injection of glucantime (435 mg of sb5+, active antimony) once per week until 10 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5251 0
size of induration with a transparent paper by an independed observer who is blind to the treatment options
Timepoint [1] 5251 0
the size of induration will be measures every 2 weeks week up to 10 weeks, 2 weeks and 3 months after the end of treatment
Secondary outcome [1] 8850 0
smear for leishman body
Timepoint [1] 8850 0
at the end of treatment, 2 weeks and 3 months after the end of treatment

Eligibility
Key inclusion criteria
age>2 years, the size of lesion<3cm, the number of lesions<4, the patients whom did not injected glucantim, the patinets whom did not receive any treatment for leishmaniasis within last month.
Minimum age
2 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, lactation, the lesions of articular area.

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 envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization
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
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 1504 0
Iran, Islamic Republic Of
State/province [1] 1504 0
Kerman

Funding & Sponsors
Funding source category [1] 4342 0
University
Name [1] 4342 0
Kerman medical university
Country [1] 4342 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] 3911 0
Hospital
Name [1] 3911 0
Afzalipour hospital
Address [1] 3911 0
Afzalipour hospital,Kerman medical university,Kerman, Iran
Country [1] 3911 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6399 0
ethical committee of Kerman medical university
Ethics committee address [1] 6399 0
Ethics committee country [1] 6399 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6399 0
Approval date [1] 6399 0
Ethics approval number [1] 6399 0
k-85/33

Summary
Brief summary
Leishmaniasis is a parasitic disease that is endemic in developing countries. 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 .the aim of this atudy is to determine the efficacy of topical terbinafine in the treatment of cutaneous leishmaniasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35067 0
Address 35067 0
Country 35067 0
Phone 35067 0
Fax 35067 0
Email 35067 0
Contact person for public queries
Name 12414 0
Armita shahesmaeili
Address 12414 0
clinical research department,Afzalipour hospital,Kerman,Iran
Country 12414 0
Iran, Islamic Republic Of
Phone 12414 0
0913-340-6291
Fax 12414 0
0098-0341-322-2270
Email 12414 0
[email protected]
Contact person for scientific queries
Name 3342 0
Saeedeh Farajzadeh
Address 3342 0
Dermatology ward,Afzalipour hospital,Kerman,Iran
Country 3342 0
Iran, Islamic Republic Of
Phone 3342 0
0913-341-4259
Fax 3342 0
0098-0341-322-2270
Email 3342 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
No additional documents have been identified.