Evaluation of efficacy of topical niosomal 2 % zinc sulfate plus intralesional glucantime in comparison with cryotherapy PLUS intralesional glucantime in the treatment of acute cutaneous leishmaniasis.
Comparing intra-lesional Glucantime plus Niosomal Zinc Sulfate to intra-lesional Glucantime plus Cryotherapy in acute form of cutaneous leishmaniasis
Design
This is a phase 2-3, Two-arm parallel group randomized trial with blinded outcome assessor
Settings and conduct
This is a randomized control study on 64 patients with cutaneous Leishmaniasis in Afzalipour Hospital, Kerman-Iran. Patients were categorized in two groups A and B whom were treated with weekly intralesional meglumine antimonite plus twice daily niosomal topical zinc sulphate and weekly intralesional glucantime plus every other week cryotherapy respectively. This study is a double-blind based on outcome assessor and analyzer
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients with duration of disease less than 6 months and with washout period of 3 month. Exclusion criteria were pregnancy, lactation, patients younger than 2 years old, those with more than 5 lesions, lesions greater than 5 cm, lesions on the face and joint areas and history of sensitization to zinc sulphate or glucantime.
Intervention groups
Patients in group A were treated with weekly intralesional meglumine antimonite (Glucantime) plus twice daily niosomal topical zinc sulphate. Patients in group B received weekly intralesional glucantime plus cryotherapy
Main outcome variables
Complete cure was based on negative leishmaniasis smear.
Treatment response was categorized into 3 groups: complete response (100% clinical improvement with negative smear result), partial response (clinical improvement more than or equal to 60%), no response (clinical improvement less than 60% or increased lesion size). Side effects were evaluated during treatment visits.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170806035524N4
Registration date:2018-05-07, 1397/02/17
Registration timing:registered_while_recruiting
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Hoda Badakhsh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 2250
Email address
m_khalili@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of topical niosomal 2 % zinc sulfate plus intralesional glucantime in comparison with cryotherapy PLUS intralesional glucantime in the treatment of acute cutaneous leishmaniasis.
Public title
evaluation of topical niosomal zinc sulphate in leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
acute cutaneous leishmaniasis(urban type)
duration less than 6 months
wash out period of 1 month
Exclusion criteria:
pregnancy
nursing
age less than 2 years old
number of lesions more than 5
sensitization to zinc sulphate or glucantime
lesions on face or joint
lesions larger than 5 centimeter
Age
From 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
double-blind; Outcome assessor and analyser would be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebne sins Ave.,Tahmasb abad Blvd., KermanTown
City
kerman
Province
Kerman
Postal code
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.Kmu.AH.REC.1395.6
Health conditions studied
1
Description of health condition studied
Acute cutaneous leishmaniaisis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Reduction in induration of the lesion
Timepoint
at BASE -LINE AND IN 2,4,6,8,10,12 WEEKS and 3 months after end of the treatment
Method of measurement
by measuring induration of the lesions (largest diameter) by transparent paper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:treatment of cutaneous leishmaniasis with weekly intralesional glucantime plus twice daily niosomal topical zinc sulphate
Category
Treatment - Drugs
2
Description
Control group: treatment of cutaneous leishmaniasis with weekly intralesional glucantime plus every other week cryotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital,Imam high way, Kerman
Full name of responsible person
Mahin aflatoonian
Street address
Afzalipour hospital,Imam high way, Kerman
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas pardakhty
Street address
Jehad Blvd,Ebn Sina Avenue, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahin aflatoonian
Position
Assistant professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
imam highway,afzalipour hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8328
Fax
Email
maaflatoonian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin aflatoonian
Position
dermatologist,dermatopathology fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
imam highway,afzalipour hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱
Phone
+98 34 3132 8328
Fax
Email
maaflatoonian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahin Aflatoonian
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Dermatology department, Afzalipour Hospital,Imam high way,Kerman
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
maaflatoonian@gmail.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
analytic data (without personal recognizable data) can be shared with other researchers.
When the data will become available and for how long
6 months after article publication
To whom data/document is available
accessibility of data can be allowed for academic research centers
Under which criteria data/document could be used
for more research in treatment of leishmaniasis
From where data/document is obtainable
via email of corresponding author
What processes are involved for a request to access data/document
after agreement between authors of the article ,data will be sent to applier via e-mail