Finding new, effective and low-risk therapies for cutaneous leishmaniasis
Design
Parallel case control nonrandom, non-blinded clinical trial on 65 patients with skin leishmaniasis
Settings and conduct
Patients of 5-60 years old having multiple smear positive cutaneous leishmaniasis lesions referred to referral clinic in Fasa city were selected.
The main three features of lesions that worth the investigation are the size of the wound, induration and the size of the lesion.
Cases will be treated with Sina-Ampholish ointment followed by fractional 1550nm laser.
This three feature is assessed before treatment and weekly for 6 weeks during treatment and then 4 weeks after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Disease duration of Less than 1 months;
Written informed consent is signed;
Patients with at least 2 skin lesions
Exclusion criteria:
Concurrent Koebner positive skin disorders;
Patient receiving immunosuppressant drugs;
Fitzpatrick Skin photo type V and VI;
Patients under 5 years old;
lesions on the face;
lesions larger than 4cm in diameter;
Patients with underlying liver or kidney disease
Intervention groups
Patients of 5-60 years old with multiple smear positive cutaneous leishmaniasis lesions who referred to the treatment center were selected.
The method of intervention is 1550nm fractional laser with resurfacing parameter of 40 mJ per MTZ (microthermal zone) weekly for up to 6 weeks plus Sina-Ampholish ointment twice daily on the lesion surface.
In each patient one typical lesion does not get treatment as control group
Main outcome variables
Healing of wounds and elimination of induration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141123020052N3
Registration date:2020-08-06, 1399/05/16
Registration timing:registered_while_recruiting
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Ahmad Reza Parhizkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 6300
Email address
parhizkara@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of combination of fractional 1550nm laser therapy plus Sina-ampholeish ointment on cutaneous leishmaniasis
Public title
Efficacy of combinig fractional 1550nm laser and topical Sina-ampholish in old world cutaneous leishnaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Less than 1months of the disease duration
Written informed consent.
at least 2 skin lesions present
Exclusion criteria:
Concurrent Koebner positive skin disorders
patient who treating under immunodeficient drugs
Skin phototype FitzPatrick V and VI
patient below 5 years old
lesions on the face
lesions of more than 4 centimeter diameter
patients who have underlying liver or kidney disease
Age
From 5 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
65
More than 1 sample in each individual
Number of samples in each individual:
2
An indurated painless purple plaque or nodule with or without central ulceration
Randomization (investigator's opinion)
Not 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
Ethics committee of Islamic Azad University Kazerun branch
Street address
Central office of Islamic Azad University., North Ghaani Ave., Shiraz Town,
City
Kazerun
Province
Fars
Postal code
7139777669
Approval date
2019-10-01, 1398/07/09
Ethics committee reference number
IR.IAU.KAU.REC.1398.106
2
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Fasa University of Medical Sciences, Ebn-Sina Square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.FUMS.REC.1399.070
Health conditions studied
1
Description of health condition studied
Skin lesions caused by cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis treatment laser
Primary outcomes
1
Description
Induration of the lesion
Timepoint
Before intervention and 1, 2, 3, 4, 5, 6 weeks after intervention and 4 weeks after the end of treatment.
Method of measurement
The degree of stiffness in touch by the researcher
2
Description
Ulcer diameter
Timepoint
Before intervention and 1, 2, 3, 4, 5, 6 weeks after intervention and 4 weeks after the end of treatment.
Method of measurement
By the ruler
3
Description
Lesion diameter
Timepoint
Before intervention and 1, 2, 3, 4, 5, 6 weeks after intervention and 4 weeks after the end of treatment.
Method of measurement
By the ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Selected skin lesions are treated in 6 pass with fractional laser of 1550nm wave length with 40mj energy in each MTZ weekly for 6 weeks. Sina-Ampholish cream used twice daily during the treatment
Category
Treatment - Devices
2
Description
Control group: one lesion with average diameter of all skin lesions is selected as control and no treatment is given.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology office of Dr.Parhizkar
Full name of responsible person
Ahmad Reza Parhizkar
Street address
Pezeshkan clinic, Hafez street
City
Fasa
Province
Fars
Postal code
7461917949
Phone
+98 71 5335 5222
Email
ahmadrparhizkar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Hossien Marhamatizadeh
Street address
Central office of Islamic Azad University., North Ghaani Ave., Shiraz Town,
City
Kazerun
Province
Fars
Postal code
7139777669
Phone
+98 71 4223 9933
Fax
Email
Drmarhamati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Ahmadreza Parhizkar
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
2
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Frajam
Street address
Vice Chancellor of Research, Fasa University of Medical Sciences, Ebn-Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 6300
Email
research@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Ahmadreza Parhizkar
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic azad university of kazerun
Full name of responsible person
Ahmadreza parhizkar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Level 3, Hafez street, next to Mellat Bank, Fasa, Fars province, Iran,
City
Fasa
Province
Fars
Postal code
7461917949
Phone
+98 71 5335 5222
Email
ahmadrparhizkar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic azad university of kazerun
Full name of responsible person
Ahmadreza parhizkar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Level 3, Hafez street, next to Mellat Bank, Fasa, Fars province, Iran,
City
Fasa
Province
Fars
Postal code
7461917949
Phone
+98 71 5335 5222
Email
ahmadrparhizkar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university of kazerun
Full name of responsible person
Ahmadreza parhizkar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Level 3, Hafez street, next to Mellat Bank, Fasa, Fars province, Iran,
City
Fasa
Province
Fars
Postal code
7461917949
Phone
+98 71 5335 5222
Email
ahmadrparhizkar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD