Protocol summary
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Study aim
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determination of the therapeutic effect of IPL laser with effective wavelength spectrum for vascular lesions on active lesions of cutaneous leishmaniasis
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Design
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This study is a parallel controlled clinical trial on 30 cutaneous leishmaniasis patients. With a randomization software, laser treatment and treatment with intralesional injection of glucantime are randomly assigned to the patients.
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Settings and conduct
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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 3 and 6 months after the first treatment session.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Intervention group: 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 6 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 10 weeks.
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Main outcome variables
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diameter of lesion induration ; photography
General information
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Reason for update
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Completion of trial and changes in actual sample size, as well as extended treatments.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140414017271N5
Registration date:
2018-11-29, 1397/09/08
Registration timing:
registered_while_recruiting
Last update:
2020-02-25, 1398/12/06
Update count:
2
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Registration date
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2018-11-29, 1397/09/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-15, 1397/06/24
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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2018-09-15, 1397/06/24
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Actual recruitment end date
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2019-05-02, 1398/02/12
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Trial completion date
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2019-12-05, 1398/09/14
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Scientific title
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Comparing the therapeutic effect of IPL with wavelength spectrum effective on vascular lesions and intralesional Glucantime in treatment of patients with acute cutaneous leishmaniasis
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Public title
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Therapeutic effect of laser on leishmaniasis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
26
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly divided into two groups based on the list of random numbers generated by a computer.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-25, 1397/05/03
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1397.398
Health conditions studied
1
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Description of health condition studied
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acute cutaneous leishmaniasis
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ICD-10 code
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B55.1
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ICD-10 code description
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Cutaneous leishmaniasis
Primary outcomes
1
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Description
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Photography of lesion
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Timepoint
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Photos are evaluated at each treatment session and then 3 and 6 months after the first treatment session.
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Method of measurement
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Camera
2
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Description
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diameter of lesion induration
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Timepoint
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Diameter of lesion induration is evaluated at each treatment session and then 3 and 6 months after the first treatment session.
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Method of measurement
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Caliper
Intervention groups
1
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Description
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Intervention group: patients with acute urban leishmaniasis with less than 3 months treatment time will be placed under treatment with IPL device every 2 weeks (up to 6 sessions)
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Category
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Treatment - Devices
2
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Description
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Control group: patients with acute urban leishmaniasis will be treated with intralesional injection of glucantime weekly for up to 10 weeks (11 sessions).
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All data can be shared after patients are made unidentifiable.
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When the data will become available and for how long
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Data can be accessible 6 months after results are published.
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To whom data/document is available
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Data will be available for researchers at universities and other scientific institutes.
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Under which criteria data/document could be used
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Carrying out analysis on data is permitted.
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From where data/document is obtainable
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Data can be accessible through sending an email to the corresponding author.
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What processes are involved for a request to access data/document
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After sending a request email to the corresponding author, data will be sent in 1 month.
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Comments
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