Comparison of combined intralesional injection of glucantime and interferon gamma with intralesional glucantime alone in the treatment of cutaneous leishmaniasis
The purpose of this study is evaluation of adding INF gamma to standard treatment for cutaneous leishmaniasis.
Fifty patients with cutaneous leishmaniasis reffered in Ghaem and Emam Reza hospitals, that they have not received any treatment for their disease in last two months and have treatment with intralesional meglumine, will be selected, and will be divided to 2 Groups of 25 people, control and intervention.
In the intervention group, glucantime and interferon gamma and in control just glucantime will be injected.
Characteristics including age, gender, duration of the injury, the biggest diameter of the induration and the place of injury will be recorded.
The patients in terms of the rate of healing, based on the change in the induration size, will be divided into 3 groups: full healing, significant healing and active lesions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012420740N2
Registration date:2015-10-21, 1394/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-21, 1394/07/29
Registrant information
Name
Fakhrozaman Pezeshkpoor
Name of organization / entity
Mashhad University of Medical Sciences, Ghaem Hospital
Country
Iran (Islamic Republic of)
Phone
+98 38012861
Email address
pezeshkpoorf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin Diseases and Leishmaniasis Research Center, Mashhad University of Medical Sciences, School of Medicine
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combined intralesional injection of glucantime and interferon gamma with intralesional glucantime alone in the treatment of cutaneous leishmaniasis
Public title
Comparison of combined intralesional injection of glucantime and interferon gamma with intralesional glucantime alone in the treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterias: Positive smear or biopsy of the lesion in terms of Amastigotes; Not sensitivity to glucantime; The patient who has indications of topical treatment based on state protocol; Less than one year past from onset of the illness; No treatment is received in at least 2 months; Not pregnant and not lactating; The patient is willing to participate in the study. exclusion criterias: No have regular visit; Secondary infection of the lesion based on clinical features and judging therapist; Use of other medications during the study.
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi),Daneshgah 16, Daneshgah Street, Mashhad, Khorasan Razavi, Iran, Islamic Republic Of
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
920211
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B50,B51,B5
ICD-10 code description
Protozoal diseases
Primary outcomes
1
Description
The rate of healing
Timepoint
Once a week up to 12 weeks after treatment
Method of measurement
Outcomes based on the percent reduction of induration: full healing (100% healing), significant healing (75%> reduce induration), relatively healing (50-75% reduce induration), low healing (25-50% reduce induration), no response (25%< reduce induration)
Secondary outcomes
1
Description
Treatment effects
Timepoint
Once a week up to 12 weeks after treatment
Method of measurement
Local or systemic clinical reactions cause of using drugs
Intervention groups
1
Description
intervention: Injection of interferon gamma with standard treatment (Injection of Glucantime).
control: Glucantime standard drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street, Mashhad, Khorasan Razavi, Iran, Islamic Republic Of
City
Mashhad
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, Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fakhrozaman Pezeshkpoor
Position
PHD
Other areas of specialty/work
Street address
Ahmad Abad Street, Ghaem Hospital, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
src@mums.ac.irpezeshkpoorf@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Fakhrozaman Pezeshkpoor
Position
PHD
Other areas of specialty/work
Street address
Ahmad Abad Street, Ghaem Hospital, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2861
Fax
+98 51 3801 2861
Email
src@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Azizi Mayvan
Position
MSC
Other areas of specialty/work
Street address
Faculty of Health
City
Mashhad
Postal code
Phone
00
Fax
Email
azizimf911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)