Objective:The aim of this phase 3,clinical study is to evaluate the effect of topical thermotherapy (with thermomed) in the treatment of anthroponotic Leishmaniasis. Design: In leishmaniasis clinic of Imam Reza hospital, twenty cases of Cutaneous Leishmaniasis will be selected accidentaly. Inclusion criteria are: confirmed diagnosis of cutaneous Leishmaniasis by PCR lesions, less than six months of duration, informed consent for participation. Exclusion Criteria are; pregnancy, more than 5 lesions, Very extensive lesions (more than ten centimeters). Setting: The lesion will be treated with thermotherapy (50 degree of Centigrade for 30 seconds) one cession and after one month, patients will be visited and the lesion changes and probable side effects would be recorded. For cases in which the considerable induration in lesions remains, treatment will be carried out once again. After 6 months of treatment, patients will be visited again and evaluated and the course of disease and possible complications would be recorded. main outcome measures: Finally, the patients will be divided into three categories in terms of lesion consistency and size (the size of induration). Early improvement: more than 50% of reduced induration during three months after treatment. Definite improvement: including early improvement and not return of lesion during in the six-month follow-up. Failure of treatment: increased the lesion size or improvement of less than 50% of lesions in 3 months follow up or return of the lesion in six months follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011816554N2
Registration date:2016-01-03, 1394/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Vahid Mashayekhi-Goyonlo
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2490
Email address
mashayekhiv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical thermotherapy ( with thermomed) in the treatment of anthroponotic Leishmaniasis in a pilot study
Public title
Evaluation of the effect of topical thermotherapy ( with thermomed) in the treatment of anthroponotic Leishmaniasis in a pilot study
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: clinical features of lesion consistent with Anthroponrtic leishmaniasis; specified L. tropica with Molecular method PCR; the patient has indication for local therapy based on clinical judgment; up to 6 months of the lesion duration; the patient already not had any treatment for cutaneous Leishmaniasis; consent for participate in this study.
Exclusion Criteria: incompetence for regular follow-up; presence of secondary infection of the lesions based on clinical features and physician judgment; Use of other treatments during the study; Very extensive lesions (more than ten centimeters); presence of necrosis and the lesions deeper than hypodermis; Lesions on the face and joints; having a pacemaker and prosthetic; pregnancies.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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(Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930460
Health conditions studied
1
Description of health condition studied
Anthroponotic Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Lesion healing
Timepoint
Three monthly
Method of measurement
Measuring the size of induration and formidability
Secondary outcomes
1
Description
Side effects
Timepoint
Three monthly
Method of measurement
Efficacy and side effects including local and systemic reactions will be recorded according to patient's report and clinician observation
Intervention groups
1
Description
Thermotherapy: one time (30 seconds at 50 ° C)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center for skin disease and cutaneous leishmaniasis
Full name of responsible person
Dr Vahid mMashayekhi
Street address
Department of dermatology, Imam Reza hospital, Ebn Sina Ave.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Mashayekhi-Ghoyonlo
Position
Associate professor of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Emam Reza hospital, Emam Reza Squre, Ebn Sina Ave.
City
Mashhad
Postal code
Phone
+98 51 3802 2490
Fax
Email
mashayekhiv@mums.ac.ir, src@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Vahid Mashayekhi-Goyonlo
Position
Associate professor of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Emam Reza hospital, Emam Reza Squre, Ebn Sina Ave.
City
Mashhad
Postal code
Phone
+98 51 3802 2490
Fax
Email
mashayekhiv@mums.ac.ir; 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
Narges Saberi
Position
Master of Science, Biostatistics student
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Health School
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
saberirn911@mums.ac.ir; src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)