Comparison of topical liposomal azithromycin plus azithromycin and azithromycin in in the treatment of cutaneous leishmaniasis.
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
Patients referred to the dermatologic and infectious clinics and the Clinic of the Dermatology Center of Isfahan Dermatology Research Center, who had the inclusion criteria mentioned, entered the study. Patient information was obtained through a questionnaire, clinical examination and photographic examination and was recorded in a checklist. The information includes the number of lesions, the size of the lesions, the location of the lesions, the patient's age, the history of the disease and the complications of azithromycin. Patients are randomly assigned into two intervention and control groups.Patients and data analyst are unaware of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: new cases of cutaneous leishmaniasis; 1-5 lesions with 3 cm and diameter more than 3 cm.
Non-Inclusion criteria: more than 5 lesions; lesions on face, neck, joint and mucosal sites or sporotrichoid like lesions; lung surface size is more than 5 Square centimeters; the patient is pregnant or breastfeeding.
Intervention groups
The intervention group included 20 oral and topical azithromycin (lesion) samples and control group with 20 oral and placebo-receiving azithromycin recipients
Main outcome variables
Lung size; complications of azithromycin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039414N1
Registration date:2019-07-27, 1398/05/05
Registration timing:retrospective
Last update:2019-07-27, 1398/05/05
Update count:0
Registration date
2019-07-27, 1398/05/05
Registrant information
Name
Atousa Hakamifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
a.hakamifard@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of topical liposomal azithromycin plus azithromycin and azithromycin in in the treatment of cutaneous leishmaniasis.
Public title
Liposomal azithromycin in cotaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New cases of cutaneous leishmaniasis
1-5 lesions with 3 cm and diameter more than 3 cm
Exclusion criteria:
More than 5 lesions
Lesions on face, neck, joint and mucosal sites or sporotrichoid like lesions
Lung surface size is more than 5 Square centimeters
The patient is pregnant or breastfeeding.
Age
From 1 year old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
The number of lesion in patients was 2 on average. But some patients also had a lesion. In general, any disease with less than 5 lesions according to the conditions of entry into the sample was included in the study and each lesion was considered as a separate sample.
Actual sample size reached:
15
More than 1 sample in each individual
Actual sample size in each individual:
2
The number of lesion in patients was 2 on average. But some patients also had a lesion. In general, any disease with less than 5 lesions according to the conditions of entry into the sample was included in the study and each lesion was considered as a separate sample.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two intervention groups (receiving oral and topical ozithromycin) and control (oral azithromycin and placebo recipients) using spss computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in both groups received oral azithromycin therapy and randomly received a placebo group and the other group receiving topical intervention, and patients were unaware of the treatment content. Information is provided to the data analyst after being ignored and tagged.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Soffeh Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.144
Health conditions studied
1
Description of health condition studied
Leishmaniasis
ICD-10 code
Infections
ICD-10 code description
L00-L08
Primary outcomes
1
Description
Leishmaniasis
Timepoint
6 weeks, 12 weeks and 6 months after treatment
Method of measurement
Digital photography
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Local topical liposomal erythromycin, which was coated every 12 hours on the surface of the surface, with an oral erythromycin capsule of 500 mg every 12 hours
Category
Treatment - Drugs
2
Description
Control group: Localized liposomal erythromycin, which was applied every 12 hours on the surface of the site, plus a daily 5 cc placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Leishmaniasis Research Center
Full name of responsible person
Atousa Hakamifard
Street address
Soffeh Ave, Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
a.hakamifard@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Hezarjerib Ave, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
a.hakamifard@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
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
Esfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezajerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
a.hakamifard@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezarjerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
a.hakamifard@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atousa Hakamifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezarjerib Ave, Isfahan University Of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
a.hakamifard@med.mui.ac.ir
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
All information is non-identifiable and can be shared after two years after printing.
When the data will become available and for how long
Two years after the publication of the article
To whom data/document is available
Physicians, assistants and specialists in the field of skin
Under which criteria data/document could be used
To compare the present information with the following information or with other therapeutic procedures
From where data/document is obtainable
Send an e-mail to a.hakamifard@med.mui.ac.ir and get permission from the research deputy of Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send an e-mail to a.hakamifard@med.mui.ac.ir and get permission from the research deputy of Isfahan University of Medical Sciences.