Comparing the therapeutic effect of IPL laser with effective wavelength spectrum on vascular lesions and intralesional Glucantime in treatment patients with acute cutaneous leishmaniasis
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Protocol summary
This study is a parallel grouped controlled clinical trial consists. Twenty six patients will be enrolled in the study. With a randomization software, laser treatment and treatment with intralesional injection of glucantime are randomly assigned to the patients.
This study is a parallel controlled clinical trial consists of twenty six patients. With a randomization software, laser treatment and treatment with intralesional injection of glucantime are randomly assigned to the patients.
This study is a parallel grouped controlled clinical trial consists. Twenty of twenty six patients will be enrolled in the study. With a randomization software, laser treatment and treatment with intralesional injection of glucantime are randomly assigned to the patients.
No blinding is done in this study. 26 patients with leishmaniasis who have a maximum lesion number of 3 and are refereed to Ghaem Hospital in Mashhad will enter the study. Follow-ups are carried out at intervals of 1,5, 3 and 6 months after the first treatment session.
Blinding is not done in this study. 26 patients with leishmaniasis who have a maximum lesion number of 3 and are refereed to Ghaem hospital in Mashhad enter the study. Follow-ups are carried out at intervals of 1,5, 3 and 6 months after the first treatment session.
No blindingBlinding is not done in this study. 26 patients with leishmaniasis who have a maximum lesion number of 3 and are refereed to Ghaem Hospitalhospital in Mashhad will enter the study. Follow-ups are carried out at intervals of 1,5, 3 and 6 months after the first treatment session.
General information
Comparing the therapeutic effect of IPL laser with effective wavelength spectrum and Glucantime on vascular lesions treatment in patients with acute cutaneous leishmaniasis
Comparing the therapeutic effect of IPL laser with effective wavelength spectrum on vascular lesions and intralesional Glucantime in treatment patients with acute cutaneous leishmaniasis
Comparing the therapeutic effect of IPL laser with effective wavelength spectrum and Glucantime on vascular lesions treatmentand intralesional Glucantime in treatment patients with acute cutaneous leishmaniasis
مقایسه اثر لیزر IPL با طیف طول موج موثر و گلوکانتیم داخل ضایعه در درمان ضایعات عروقی در مبتلایان به لشمانیوز جلدی حاد
مقایسه اثر لیزر IPL با طیف طول موج موثر بر ضایعات عروقی و گلوکانتیم داخل ضایعه در درمان مبتلایان به لشمانیوز جلدی حاد
مقایسه اثر لیزر IPL با طیف طول موج موثر بر ضایعات عروقی و گلوکانتیم داخل ضایعه در درمان ضایعات عروقی در مبتلایان به لشمانیوز جلدی حاد
Protocol summary
Study aim
determination of the therapeutic effect of IPL laser with effective wavelength spectrum for vascular lesions on active lesions of cutaneous leishmaniasis
Design
This study is a parallel controlled clinical trial consists of twenty six patients. With a randomization software, laser treatment and treatment with intralesional injection of glucantime are randomly assigned to the patients.
Settings and conduct
Blinding is not done in this study. 26 patients with leishmaniasis who have a maximum lesion number of 3 and are refereed to Ghaem hospital in Mashhad enter the study. Follow-ups are carried out at intervals of 1,5, 3 and 6 months after the first treatment session.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Cases with confirmed urban leishmaniasis based on clinical presentation and skin smear result, indication of topical treatment, maximum lesion number of 3, duration of the disease is less than 3 months, no laceration on the lesion.
exclusion criteria: pregnancy, photosensitivity, positive Kobner test skin disease
Intervention groups
Intervention group:13 patients with acute urban leishmaniasis with less than 3-month treatment time will be placed under treatment with IPL laser device every 2 weeks (up to 4 sessions). The treatment of first session for the intervention group is carried out using laser Palomar system with 38-40 J / cm2 fluence. Afterwards, the parameters of the device in each session will be set aiming at creating purpura and ecchymorous.
Control group: Patients with acute urban leishmaniasis will be treated with intralesional injection of glucantime weekly for up to 8-10 weeks.
Main outcome variables
diameter of lesion induration ; photography
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140414017271N5
Registration date:2018-11-29, 1397/09/08
Registration timing:registered_while_recruiting
Last update:2018-12-18, 1397/09/27
Update count:2
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Yalda Nahidi
Name of organization / entity
department of dermatology, Ebne Sina St, Emam Reza hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2490
Email address
nahidiy@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-15, 1397/06/24
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effect of IPL laser with effective wavelength spectrum on vascular lesions and intralesional Glucantime in treatment patients with acute cutaneous leishmaniasis
Public title
Therapeutic effect of laser on leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cases with confirmed urban leishmaniasis based on clinical presentation and skin smear result
Indication for topical treatment
Maximum lesion number of 3
Disease duration less than 3 months
No damage to the lesion
Informed consent to participate in the study
Exclusion criteria:
pregnancy
photosensitivity
positive Kobner test skin disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups based on the list of random numbers generated by a computer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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 (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-07-25, 1397/05/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.398
Health conditions studied
1
Description of health condition studied
acute cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Photography of lesion
Timepoint
Photos are evaluated at each treatment session and then 1.5, 3, and 6 months after the first treatment session.
Method of measurement
Camera
2
Description
diameter of lesion induration
Timepoint
Diameter of lesion induration is evaluated at each treatment session and then 1.5, 3, and 6 months after the first treatment session.
Method of measurement
Caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:13 patients with acute urban leishmaniasis with less than 3 months treatment time will be placed under treatment with IPL laser device every 2 weeks (up to 4 sessions)
Category
Treatment - Devices
2
Description
Control group: Patients with acute urban leishmaniasis will be treated with intralesional injection of glucantime weekly for up to 8-10 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Imam Raza Hospital
Full name of responsible person
Zahra Tafazzoli
Street address
Ghaem Hospital, Ahmad Abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9173699199
Phone
+98 51 3801 2493
Email
Tafazzoliz951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?