Comparing improvement of lesions in leishmaniasis patients with two treatment methods including trichloroacetic Acid (TCA) and interalesional meglumine antimoniate (Glucantime) for the treatment of Lupoid leishmaniasis
The aim of this study is to compare combined intra-lesional injection of Glucantime and topical application of aqueous solution of trichloroacetic Acid (TCA) 50% in the treatment of cutaneous leishmaniasis. A total of 120 patients who their cutaneous leishmaniasis will be diagnosed by direct skin smear via Giemsa method or dermal biopsy and their clinical lesion course is less than 6 months will be recruited to receive interalesional glucantime (until the lesions are completely indurated to 1 mm of their surrounding area) or topical solution of TCA until the lesion is frosted for 8 weeks. The changes of lesion indurations in every follow up visit will be measured as primary outcome measure. Patients will be followed up for 3 months after the final therapeutic course and lesion indurations and possible side effects will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101313862N6
Registration date:2011-04-11, 1390/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-11, 1390/01/22
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Funded by Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2009-11-26, 1388/09/05
Expected recruitment end date
2011-08-27, 1390/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing improvement of lesions in leishmaniasis patients with two treatment methods including trichloroacetic Acid (TCA) and interalesional meglumine antimoniate (Glucantime) for the treatment of Lupoid leishmaniasis
Public title
Comparing improvement of lesions in leishmaniasis patients with two treatment methods including trichloroacetic Acid (TCA) and interalesional meglumine antimoniate (Glucantime) for the treatment of Lupoid leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of cutaneous leishmaniasis in less than 6 months prior to the study that their disease has been approved by direct smear and stained with Giemsa or positive dermal biopsy, 3-month treatment-free interval from the last treatment course
Exclusion criteria: pregnancy, breast-feeding, any administration of any other medication during the study that has anti-leishmaniasis ingredient during 2 last months, history of severe renal impairment, pulmonary and cardiovascular disease
Age
To 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central building of Mashhad University of Medical Sciences
City
Mashhad
Postal code
86721
Approval date
2009-09-27, 1388/07/05
Ethics committee reference number
86721
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous Leishmaniasis
Primary outcomes
1
Description
complete healing
Timepoint
first time at 8th weeks after treatment and the second time in follow up visit after 3 months of commencement of the study
Method of measurement
Measuring the width and induration and ulcer size
Secondary outcomes
1
Description
side effects
Timepoint
at each follow up visit
Method of measurement
Physical examination
Intervention groups
1
Description
Interalesional Glucantime injection, until the lesion with 1 mm of its surrounding is completely infiltrated, in size basis until the lesion is completely infiltrated and indurated, weekly up to 8 weeks
Category
Treatment - Drugs
2
Description
Topical TCA 50%, after the lesion is frosted, the lesion site without washing is covered with topical cream, weekly until improvement time and will repeat up to 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center of Skin Disease and Cutaneous leishmaniasis, Ghaem Hospital
Full name of responsible person
Dr Mahnaz Banihashemi
Street address
Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Mashhad University of Medical Sciences, Dr Jalil Tavakol Afshari
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad University of Medical Sciences
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
Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Hasan Amir Soleimani
Position
General Practitioner
Other areas of specialty/work
Street address
Research center of skin diseases and leishmaniasis, Office building, Ghaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
src@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology, Ghaem Hospital, Mashad University of Medical Sciences
Full name of responsible person
Dr Mahnaz Banihashemi
Position
Associate Professor of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Ghaem Hospital, Mashad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1841 0135
Fax
Email
banihashemim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zamen Salamati Institute of healthcare services
Full name of responsible person
Hadis Yousefzadeh
Position
Master of Sciences, Biologist
Other areas of specialty/work
Street address
No. 86, Ibn Sina ave.,Zamen Salamati Institute
City
Mashhad
Postal code
9183785195
Phone
+98 51 1841 4499
Fax
Email
telehealth.ir@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)