Evaluation of the effect of topical Sertacanazole plus cryotherapy in the treatment of cutaneous leishmaniasis and its comparison with cryotherapy with placebo
Design
Randomized controlled clinical trial, with two parallel groups, double blind,
Settings and conduct
Both types of cream were packed in 30 g coded and similar encoded packets and were provided to patients by an expert who did not know the type of patient.
Participants/Inclusion and exclusion criteria
Entry requirements include men and women at least 12 years of age, less than 3 lesions, lesions less than 3 cm, positive leishmania smear and less than 4 months of laceration.
Exit conditions include infectious lesions, longevity for more than 4 months, facial lesions, anti-leishmaniasis in the past month and allergic to sertanoconazole.
Intervention groups
Patients taking medication (Sertacanazole) and patients taking placebo (cold cream)
Main outcome variables
Area of Cutaneous leishmaniasis lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040195N1
Registration date:2018-08-01, 1397/05/10
Registration timing:retrospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Farideh Jowkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
jowkarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
empty
Scientific title
Evaluation of Topical Sertaconazole Efficacy with Cryotherapy versus Cryotherapy with placebo in Treatment of Cutaneous Leishmaniasis
Public title
Evaluation of Topical Sertaconazole Efficacy with Cryotherapy versus Cryotherapy with placebo in Treatment of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 12 years old
Numbers of lesions are less than 3
Diameter of the lesions are less than 3 cm
Positive smear for leishmaniasis
Less than 4 months from the onset of the lesion
Exclusion criteria:
Pregnant and lactating women
Unwillingness to participate in the study
Known cases of systemic diseases
Age
From 12 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into two groups including drug (A) and placebo (B) using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both types of cream were packed in 30 g coded and similar encoded packets and were provided to patients by an expert who did not know the type of patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.SUMS.med.REC.1395.6131
Health conditions studied
1
Description of health condition studied
Cutaneus Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Area of the lesion
Timepoint
The 0, 2, 4 and 8 weeks
Method of measurement
Using the rule and measurement of the diameters of lesion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For these patients, once a week, cryotherapy was performed, for the maximum duration of 8 weeks and used Sertaconazole QD for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: For these patients, once a week, cryotherapy was performed, for the maximum duration of 8 weeks and used cold cream QD for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Shahid Faghihi Hospital
Full name of responsible person
Dr. Farideh Jowkar
Street address
Shahid Faghihi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
jowkarf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Shiraz University of medical Sciences, Research vice, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7252
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Farideh Jowkar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences Molecular Dermatology research center
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Fax
Email
jowkarf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Farideh Jowkar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences Molecular Dermatology research center
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Fax
Email
jowkarf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Farideh Jowkar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shiraz University of Medical Sciences Molecular Dermatology research center
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Fax
Email
jowkarf@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document