Study of the additional effect of topical ciprofloxacin on intralesional injection of glucantime in the treatment of cutaneous leismaniasis
Design
This study is a randomized controlled trial study of phase three with parallel groups performed on two groups of 26 patients with anterior leishmaniasis. Random allocation software is used for randomization.
Settings and conduct
This clinical trial study is performed as two Socors in 1399 on leishmaniasis patients who refer to the leishmaniasis clinic of Ghaem Hospital in Mashhad for treatment. All patients receive routine leishmaniasis treatment (glucantime injection). In one group, ciprofloxacin ointment is prescribed, and in the second group, placebo.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Leishmaniasis with direct smear confirmation, clinical course of lesions less than 6 months, no history of leishmaniasis treatment 2 months before entering the study.
Exclusion Criteria: age less than 18 years and over 70 years, pregnancy and lactation, use of other therapies during the study period, specific forms of leishmaniasis such as erysipeloid zosteriform and vasospermic and lopoid form
Intervention groups
In this study, 52 patients with leishmaniasis were distributed in two groups of 26 patients. Both groups receive routine treatment for leishmaniasis, which involves injecting glucantime. Patients in the first group receive an ointment containing ciprofloxacin to be rubbed twice a day at the site of the leishmaniasis wound during the treatment period. In the second group (control), placebo ointment containing Vaseline is prescribed to be rubbed in the same position and duration.
Main outcome variables
improvement, improvement time, size of scare
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N46
Registration date:2020-05-25, 1399/03/05
Registration timing:prospective
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the additional effect of topical ciprofloxacin on intralesional injection of glucantime in the treatment of cutaneous leismaniasis
Public title
effect of adding Cyprofloxacin ointment in treatment of Lishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a Lishmaniasi with direct smear confirmation
The clinical course of the lesion is less than 6 months
No history of leishmaniasis treatment 2 months before entering the study
Exclusion criteria:
Pregnancy and lactation
Use of other therapies during the study period
Specific forms of leishmaniasis, such as erysipeloid, zosteriform, vasoprotective, and lopoid
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between the two groups is done by Random Allocation Software. In the mentioned software, the volume of the total sample size and the number of groups are entered to the software. The randomization unit in the mentioned software is individual. The software output is a grouped list that randomly distributes the number of samples in two groups. According to the list, patients are distributed in two groups according to the time of referral so that the sample size reaches the required number in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is conducted in double blind forms. Patients are unaware of the contents of the topical ointment received. In this way, the medicine is prepared by one of the staff of the clinic who is not in the process of studying in the same packaging and is given to the project executor for prescribing to the patients. Data collection work is also performed by an infectious disease specialist who is unaware of the type of prescription ointment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghaem Street , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
8434193474
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
399412
Health conditions studied
1
Description of health condition studied
Cutaneous Lishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
improvement status
Timepoint
Every week for 8 weeks.
Method of measurement
Physical examination
2
Description
improvement time
Timepoint
Every week for 8 weeks.
Method of measurement
Physical examination
3
Description
size of scare
Timepoint
Ent of treatment
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group treated with topical ointment ciprofloxacin liposomes twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated.
Category
Treatment - Drugs
2
Description
Control group: In this group treated with placebo of topical ointment twice a day with a weekly injection of glucocorticoids into the lesion for 8 weeks. Then the size of the lesion (induction) at the time before and 1.5 month after will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mitra Akefi
Street address
Ghaem hospital, Ghaem street, Mashahd, Iran
City
Mashahd
Province
Razavi Khorasan
Postal code
8434193474
Phone
+98 51 3668 2174
Email
mitra.akefi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Dadgar
Street address
Rsearch faculty, Mashhad University of Medical Sciences, Ghaem street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
8434193474
Phone
+98 51 3668 2174
Email
Dadgarmm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Javad Yazdanpanah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of infectious diseases, Ghaem hospital, ghaem street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
8434193474
Phone
+98 51 3669 2174
Email
yazdanpanahmj@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamadjavad Yazdanpanah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Department of Infectious diseses, Ghaem hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
8434193474
Phone
+98 51 3800 2109
Email
yazdanpahnahmj@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, Isfahan University of Medical sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
0098 37928081
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to the government agency and cannot be published