Investigation of the therapeutic effect of diphencyprone induced local hypersensitivity on treatment of acute urban leishmaniasis with intralesional injection of glucantime
Investigation of the therapeutic effect of diphencyprone induced local hypersensitivity in treatment of acute leishmaniasis
Design
This clinical trial has a control group, is randomized through a list of random numbers by a computer, with parallel groups and is carried out without blinding.
Settings and conduct
No blinding is done in this study and it will be performed on patients with acute leishmaniasis referring to Imam Reza Hospital of Mashhad. Patients will be observed at the onset of treatment and then weekly up to 12 weeks and size of lesions using a ruler in both groups, the complications and response to treatment and the time required for treatment will be recorded in each session.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Positive direct smear or biopsy of the lesion in terms of Leishman body, lesion in limbs, dry leishmaniasis, patient has an indication of topical treatment, a maximum of 6 months has elapsed since the onset of the lesion.
Exclusion Criteria: Sensitivity to intralesional glucantime, presence of secondary infection in the lesion, pregnancy or breastfeeding
Intervention groups
Control group: Patients will undergo treatment with intralesional glucantime (produced by the French company Sanofi) weekly.
Intervention group:At the same time as intralesional injection of glucantime, after sensitization with 2% diafeneceprone (produced by the American company Sigma) solution on the upper arm, increasing doses of diphencyprone will be used weekly up to the development of eczema and weakly treatment will continue until complete recovery with a sensitization dose.
Main outcome variables
rate of recovery in both groups, the time required for the lesions to heal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140414017271N6
Registration date:2019-02-17, 1397/11/28
Registration timing:registered_while_recruiting
Last update:2019-02-17, 1397/11/28
Update count:0
Registration date
2019-02-17, 1397/11/28
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
2017-11-01, 1396/08/10
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the therapeutic effect of diphencyprone induced local hypersensitivity on treatment of acute urban leishmaniasis with intralesional injection of glucantime
Public title
Investigation of the effect of diphencypron on treatment of acute urban leishmaniasis with intralesional injection of glucantime
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive smear or biopsy of the lesion in terms of Leishman body
Lesion in limbs
dry leishmaniasis
The patient has an indication of topical treatment based on the judgment of the therapist and the national protocol for leishmania
A maximum of 6 months has elapsed since the onset of the lesion
The patient has an informed consent to participate in the study.
Exclusion criteria:
Sensitivity to intralesional injection of glucantime
The presence of secondary infection in the lesion based on the researcher's judgment
Pregnancy or breastfeeding
Wet leishmaniasis, Lupoid, Sporotricoid
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done through the random allocation list by PASS software.
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
2017-02-08, 1395/11/20
Ethics committee reference number
IR.MUMS.fm.REC.1395.550
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
The rate of recovery in the two groups
Timepoint
Every week after the injection up to 12 weeks
Method of measurement
Size of the lesions will be recorded using a ruler and stiffness and induration will also be recorded based on examination in each session.
2
Description
The amount of time needed for the lesions to heal
Timepoint
Every week until lesion recovery
Method of measurement
Based on the number of weeks passed until recovery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the same time as intralesional injection of glucantime, after sensitization with 2% diphencyprone (produced by the American corporation Sigma)solution on the upper arm, increasing doses of diphencyprone will be used weekly up to the development of eczema (erythema and itching for at least 2 days) and weakly treatment will continue until complete recovery with a sensitization dose.
Category
Treatment - Drugs
2
Description
Control group: Patients undergoing intralesional injection of glucantime (produced by the French corporation Sanofi) will continue treatment weekly until complete recovery.