Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000114246
Ethics application status
Not yet submitted
Date submitted
8/12/2008
Date registered
18/02/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of oral terbinafine in the treatment of cutaneous leishmaniasis
Scientific title
A comparison between combination therapy of oral terbinafine and cryotherapy with systemic glucantime and cryotherapy in the treatment of cutaneous leishmaniasis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cutaneous leishmaniasis 4095 0
Condition category
Condition code
Skin 4290 4290 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
oral terbinafine for 4 weeks in a dose of 62.5 mg twice daily for those weighted less than 20 kg, 125 mg twice daily for those weighted 20-40 kg and 250 mg twice daily for those above 40 kg plus cryotherapy at
-196 celsius ( liqiud nitrogen) once every other week for 4 weeks; and
applied per treated site (infected site) for 5-10 sec
Intervention code [1] 3805 0
Treatment: Drugs
Comparator / control treatment
intramascular glucantime (435 mg of sb5+, active antimony vial): 15 mg/kg/day of active ingredient ( antimony) daily for 3 weeks plus cryotherapy at -196 celsius ( liqiud nitrogen) once every other week for 4 weeks; and applied per treated site (infected site) for 5-10 sec
Control group
Active

Outcomes
Primary outcome [1] 5176 0
size of induration of the lesion by transparent paper
Timepoint [1] 5176 0
before,mid and end of treatment
Secondary outcome [1] 8720 0
smear of the lesion for leishman body
Timepoint [1] 8720 0
before,mid and end of treatment

Eligibility
Key inclusion criteria
all of the patients with cutaneous leishmaniasis
Minimum age
2 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy,lactation,cardio-vascular diseases,renal disease,liver disease

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 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
Not yet recruiting
Date of first participant enrolment
Anticipated
8/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1462 0
Iran, Islamic Republic Of
State/province [1] 1462 0
Kerman

Funding & Sponsors
Funding source category [1] 4260 0
University
Name [1] 4260 0
kerman medicl university
Country [1] 4260 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
kerman medical university
Address
dermatology department,Afzalipour hospital,Kerman,Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3833 0
Other
Name [1] 3833 0
kerman leishmaniasis research center
Address [1] 3833 0
Kerman leishmaniasis research center, Afzalipour medical university,Kerman ,Iran
Country [1] 3833 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6312 0
Ethics committee address [1] 6312 0
Ethics committee country [1] 6312 0
Date submitted for ethics approval [1] 6312 0
07/12/2008
Approval date [1] 6312 0
Ethics approval number [1] 6312 0

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 [ sb]
Other treatment for cutaneous leishmaniasis are intralesinal injection of meglomine antimonate, terbinafine , paramonycin ointment , and physical treatment including cryotherapy (cryosurgery) and therapy .Total clearance or marked improvement by systmic glucantime is reported in 30%.
In 1997a pilot study was performed on 27 cutaneous leishmaniasis lesions with terbinafine and 71.5% improvement (28.5% complate recovery and 43% partial recovery) was reported in the pilat study, efficacy of oral terbinafine used for cutaneous leishmaniasis was high and worthy .
The present trial was designed to evaluat the efficacy of combination therapy by terbinafine and cryotherapy in the treatment of CL. Compared with systemic glocantime and criyotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35017 0
Address 35017 0
Country 35017 0
Phone 35017 0
Fax 35017 0
Email 35017 0
Contact person for public queries
Name 12364 0
Armita Shahesmaeili
Address 12364 0
clinical research department,Afzalipour hospital,Kerman,Iran
Country 12364 0
Iran, Islamic Republic Of
Phone 12364 0
09133406291
Fax 12364 0
0098-0341-3222270
Email 12364 0
[email protected]
Contact person for scientific queries
Name 3292 0
Saeedeh Farajzadeh
Address 3292 0
dermatology department,Afzalipour hospital,Kerman,Iran
Country 3292 0
Iran, Islamic Republic Of
Phone 3292 0
0098-0913-341-4259
Fax 3292 0
0098-0341-3222270
Email 3292 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.