Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis in comparison with intralesional antimoniate alone
Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis in comparison with intralesional antimoniate alone
Design
This randomized clinical trial has control group, parallel groups without blinding and is carried out on 100 patients with cutaneous leishmaniasis
Settings and conduct
100 patients referring to Cutaneous Leishmanaisis Clinics of Imam Reza and Ghaem Hospitals are selected, whose diagnosis with cutaneous leishmanaisis is confirmed using direct smear and have not received any treatment for their disease and are randomly assigned to two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria : positive direct smear of the lesion in terms of leishman bodies, less than six month has elapsed since the manifestation of lesion, patient has not received any previous treatment for cutaneous leishmaniasis, location of lesion is either on upper limbs or face.
Exclusion criteria : sensitivity to glucantime (severe topical reaction, anaphylaxis), existence of secondary infection in lesion, dapsone side effects including methemoglobinemia, hemolytic anemia, agranulocytosis, peripheral neuropathy, hypersensitivity
Intervention groups
Intervention group : weekly intralesional injection of glucantime starts for 6 weeks in addition to 1 mg/kg of oral dapsone daily and in the case that primary control tests are normal, dapson dosage will increase to 2 mg/kg.
Control group : treatment is carried out with weekly intralesional glucantime injection for 4-8 weeks.
Main outcome variables
evaluation and comparison of the course of response to therapy and rate of recovery after initiation of treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140211016554N4
Registration date:2019-04-28, 1398/02/08
Registration timing:retrospective
Last update:2019-04-28, 1398/02/08
Update count:0
Registration date
2019-04-28, 1398/02/08
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
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
2012-06-12, 1391/03/23
Actual recruitment end date
2014-09-17, 1393/06/26
Trial completion date
2014-09-17, 1393/06/26
Scientific title
Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis in comparison with intralesional antimoniate alone
Public title
Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive direct smear of the lesion in terms of leishman bodies
patient has indication of topical treatment according to the physician
less than six month has elapsed since the manifestation of lesion
patient has not received any previous treatment for cutaneous leishmaniasis
intervention group has normal values for CBC;G6PD;LFT
location of lesion is either on upper limbs or face
Exclusion criteria:
sensitivity to glucantime (severe topical reaction, anaphylaxis).
absence of regular follow-ups
existence of secondary infection in lesion
use of other treatments during the study
dapsone side effects including methemoglobinemia, hemolytic anemia, agranulocytosis, peripheral neuropathy, hypersensitivity
Age
From 10 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization will be carried out using table of random numbers produced 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
9138813944
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
900689
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Change in size of the lesion
Timepoint
At the end of each week
Method of measurement
based on lesion induration measured by a caliper
Secondary outcomes
1
Description
side effects
Timepoint
weekly
Method of measurement
clinical evaluation
Intervention groups
1
Description
In control group, patients receive intralesional glucantime injection weekly for 4-8 weeks.
Category
Treatment - Drugs
2
Description
In intervention group, weekly intralesional injection of glucantime starts for 6 weeks in addition to 1 mg/kg of oral dapsone daily and in the case that primary control tests are normal, dapson dosage will increase to 2 mg/kg.