Comparing the effect of two therapeutical methods including intralesional injection of glucantime alone and with low-level laser therapy in the treatment of acute cutaneous leishmaniasis
Determination and comparison of the improvement of acute cutaneous leishmaniasis lesions in patients undergoing intralesional injection of glucantime with and without low-level laser therapy
Design
A randomized single-blind clinical trial, with the parallel groups
Settings and conduct
In this study, 54 patients with acute cutaneous leishmaniasis will be included in the study and randomly divided into two groups. Patients in the first group will be treated only with intralesional glucantime injection and patients in the second group will be treated with low-level laser in addition to glucantime injection. The extent of lesion healing will then be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria are proven diagnosis of acute rural cutaneous leishmaniasis by testing, the number of lesions of less than 4, the disease course of fewer than 100 days, lesions size of less than 3 cm, no lesion on the eyelid (within a distance of less than 2 cm from the eyelid), aged more than 5 years old and no lesion on the cartilage or joint and face. Exclusion criteria also are the presence of sporotrichoid or satellite lesions, taking immunosuppressive drugs during the last 6 months, a history of receiving topical or systemic anti-leishmaniasis treatment in the last month.
Intervention groups
Control group: Patients in the first group are treated only with intralesional injection of glucantime. The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion becomes white. Intervention group: Patients in the second group are also treated with an intralesional injection of glucantime (similar to the control group). In addition, patients were treated by a low-level laser using an 820 nm probe, 3 times a week for a total of 10 sessions . Topical treatment with injectable glucantime lasts up to 8 weeks.
Main outcome variables
Lesion healing; Lesion area; Recurrence of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N14
Registration date:2020-12-07, 1399/09/17
Registration timing:prospective
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
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
Comparing the effect of two therapeutical methods including intralesional injection of glucantime alone and with low-level laser therapy in the treatment of acute cutaneous leishmaniasis
Public title
The effect of intralesional injection of glucantime with low-level laser therapy in the treatment of acute cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proven diagnosis of acute rural cutaneous leishmaniasis by testing
The number of lesions of less than 4
The disease course of fewer than 100 days
Lesion size of less than 3 cm
No lesion on the eyelid (less than 2 cm from the eyelid)
Aged over 5 years old
No lesion on cartilage or joint and face
Exclusion criteria:
Presence of sporotrichoid lesions or satellite lesions
Taking immunosuppressive drugs during the last 6 months
The history of receiving topical or systemic anti-leishmaniasis treatment in the past month
Lack of consent to participate in the study
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
54 eligible patients will be simply randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. In this way, each of the generated codes will be assigned to a patient by chance, and therefore that patient will be studied in one of the two groups according to the code.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that in this study both groups will be undergone glucantime injection and only one of these two groups will be treated with low-level laser therapy, so the patient and the care provider are aware of the type of intervention, but the researcher, results' evaluator, and data analyst will not have information of the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.MUI.MED.REC.1399.630
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
Lesion healing
Timepoint
The first to twelfth weeks from the beginning of the intervention
Method of measurement
Observation
2
Description
Lesion area
Timepoint
The first to twelfth weeks from the beginning of the intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
Recurrence of the lesion
Timepoint
Three months and six months after the intervention
Method of measurement
Observation
Intervention groups
1
Description
Control group: Patients in the first group are treated only with intralesional injection of glucantime(Sanofi Company). The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks.
Category
N/A
2
Description
Intervention group: Patients in the second group are also treated with an intralesional injection of glucantime. The patient receives a topical injection of glucantime 0.5 to 1.5 cc per week per lesion; So that all around the lesion (one-millimeter ring around it) becomes white. Topical treatment with injectable glucantime lasts up to 8 weeks. In addition, patients were treated by a low-level laser using an 820 nm probe 3 times a week for a total of 10 sessions at the intensity of 48 J/cm2 for 30 seconds and then at the intensity of 9.6 J/cm2 for 2 minutes