Cutaneous leishmaniasis is one of difficulties in our country and different treatments have been used for it. Each of these treatments has its own benefits and dangers. The goal of this study is to prove better efficacy of fluconazol 400mg daily rather than 200mg daily for the treatment of cutaneous leishmaniasis. According to the statistical calculations, sample size of our study is 94 cases. These patients will be selected from patients who refer to Shiraz Faghihi hospital for treatment. Inclusion criteria: age over 12 years; positive PCR for leishmanisis and no treatment during two months ago; duration of disease lower than 4 months. Exclusion criteria: pregnancy; breast feeding; possibility of pregnancy in future; number of lesion over ten; history of liver disease and high BUN or Cr. Patients will be divided into two groups. The patients who set in odd numbers take oral fluconazol 200mg/daily and the patients who set in even numbers take oral fluconazol 400mg/daily. Then response to the treatment defines by decrease or elimination of induration and size of the lesions and re-epithelialization . The patients follow every two week for six weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710221542N1
Registration date:2009-05-18, 1388/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-05-18, 1388/02/28
Registrant information
Name
Fariborz Hayati
Name of organization / entity
Shiraz University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 71 1227 6809
Email address
fhayati@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of medical scienses
Expected recruitment start date
2007-12-21, 1386/09/30
Expected recruitment end date
2009-02-19, 1387/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two regimens of fluconazol 200 mg and 400 mg daily in the treatment of cutaneous lieshmaniasis
Public title
Comparison of two regimens of fluconazol in treatment of cutaneous lieshmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 12 years, positive PCR for leishmanisis and no treatment in two months ago, duration of disease is lower than 4 months.
Exclusion criteria: pregnancy, breast feeding, possibility of pregnancy in future, number of lesion over ten, history of liver disease and high BUN or Cr.
Age
From 12 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Scienses
Street address
Zand Karim khan Bolvar
City
Shiraz
Postal code
7134844119
Approval date
2008-12-05, 1387/09/15
Ethics committee reference number
ct-87-3996
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
reepithelialization
Timepoint
every two week
Method of measurement
observation
2
Description
size of lesion
Timepoint
every two week
Method of measurement
with ruler
3
Description
Induration of lesion
Timepoint
every two week
Method of measurement
physical examination
Secondary outcomes
1
Description
Rising of liver enzyme, BUN and Cr
Timepoint
every two week
Method of measurement
Blood sample and laboratory measurment
2
Description
Nausea and vomitting
Timepoint
every two week
Method of measurement
History
Intervention groups
1
Description
First group: fluconazol 200mg/daily for six weeks
Category
Treatment - Drugs
2
Description
Second group: fluconazol 400mg/daily for six weeks
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Faghihi Hospital
Full name of responsible person
Hayati Fariborz
Street address
Faghihi Hospital- Zand Karimkhan Bolvar
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Scienses
Full name of responsible person
Dabaghmanesh mohammad hosain MD
Street address
Zand Karimkahn Bolvar - Shiraz University of Medical Scienses
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?