Comparative Assessment of Sodium Stibogluconate/Meglumine Intralesional Therapy Versus Combination of Thermal Therapy with Sodium Stibogluconate/Meglumine intralesional Therapy for skin lesions in Cutaneous Leishmaniasis in Pakistan
1. To compare efficacy and safety of sodium stibogluconate/meglumine intralesional therapy in combination with local-thermal therapy and alone
3. To identify reduction in number of intralesional therapy sessions when combined with thermal therapy.
Design
open label, parallel group, randomized control trial
Settings and conduct
Public Sector Clinic in endemic area. Patients, fulfilling the criteria will be randomly assigned to treatment or control group after consent process. stratified randomization technique will be used
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
02 – 80 years of age, either gender, with diagnosis of cutaneous leishmaniasis ( CL ) by direct examination under microscopy, voluntarily agreeing to participate in the study and complying with study follow-up visits will be enrolled.
Exclusion Criteria:
• Other forms of Leishmaniasis
• Patients already receiving treatment for CL
• Known hypersensitivity to sodium stibogluconate/meglumine
• Pregnancy/lactation
• Comorbidities which affecting follow-up of study
Intervention groups
On first visit treatment group will have thermotherapy and control group will receive Meglumine. On subsequent weekly visits both groups will receive meglumine intralesional.
Main outcome variables
The primary outcome will be treatment response in randomly assigned participants assessed at 4th,8th & 12th week post-treatment. The appearance, induration and size of skin lesion will be measured (using regular scale/measuring tape) .Complete response means complete re-epithelialization with no signs of inflammation .Partial response means decrease in lesion size not more than 50%, without appearance of epidermal crease while failure to response meant no re-epithelialization or a positive direct smear at the end of treatment, at 8th or 12th week of treatment. Safety outcome will be observed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220529055013N2
Registration date:2024-02-02, 1402/11/13
Registration timing:registered_while_recruiting
Last update:2024-02-02, 1402/11/13
Update count:0
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
Fauzia Gilani
Name of organization / entity
National University of Science & Technology
Country
Pakistan
Phone
+92 51 2300714
Email address
fauziagilani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-01, 1402/11/12
Expected recruitment end date
2025-02-01, 1403/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Assessment of Sodium Stibogluconate/Meglumine Intralesional Therapy Versus Combination of Thermal Therapy with Sodium Stibogluconate/Meglumine intralesional Therapy for skin lesions in Cutaneous Leishmaniasis in Pakistan
Public title
Comparative Assessment of Standard of Care Intralesional Therapy Versus Combination of Thermal Therapy with Standard of care intralesional Therapy for skin lesions in Cutaneous Leishmaniasis in Pakistan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cutaneous leishmaniasis by direct examination under microscopy
voluntarily agreeing to participate in the study and complying with study follow-up visits will be considered for enrollment.
Exclusion criteria:
• Other forms of Leishmaniasis i.e., mucocutaneous and/or visceral leishmaniasis (clinical exclusion)
Patients already receiving treatment for Cutaneous Leishmaniasis• Known hypersensitivity to stibogluconate/meglumine antimoniate
Pregnancy/lactation
Comorbidities or other illness which may hinder the completion and follow-up of study
Age
From 2 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
132
More than 1 sample in each individual
Number of samples in each individual:
2
Incase of failure of response (no re-epithelialization or a positive direct smear at the end of treatment), a second sample will be taken.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with Cutaneous Leishmaniasis presenting to clinical practice will be invited to participate in the study, after being diagnosed by microscopy. All the patients fulfilling the inclusion/exclusion criteria will be formally consented by data collector for participating in the study. Patients who will voluntarily agree to participate and comply with study protocol will be randomized to either treatment or control group by data collector. Stratified block randomization method will be used in this study, with patients stratified for number/size of skin lesion (mild to moderate/ severe disease) and age. Only those participants/guardian/parents of participants who will voluntarily consent to participate in the study will be enrolled.
In following circumstances, the subjects may be withdrawn from the study prior the expected completion:
• Failure of subject to adhere to the protocol requirements
• Subject consent withdrawal
Randomization sequences will be generated and secured in opaque envelopes and will be kept in lock & key in separate room which will be only opened at the time of consent taking and randomization.
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
National Bioethics Committee
Street address
Health Research Institute, Shahrah-e-Jamhuriat, Off Constitution Avenue, Sector G-5/2, Islamabad
City
Islamabad
Postal code
44000
Approval date
2021-12-24, 1400/10/03
Ethics committee reference number
Ref: No.4-87/NBC-562/21/962
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
1. Assessment of treatment efficacy in terms of treatment response among both study groups, assessed after 4-6 therapy sessions
Timepoint
Week 0, week 4, Week 8, Week 12
Method of measurement
Treatment Response labelled as: Complete response (complete re-epithelialization, disappearance of edema, induration, and other signs of inflammation), Partial response (decrease in lesion size not more than 50%, without appearance of epidermal crease)• Failure to response (no re-epithelialization).
Secondary outcomes
1
Description
safety adverse effects
Timepoint
0week, 4 weeks, 8 weeks, 12 weeks
Method of measurement
Assessment of treatment safety in terms of occurrence of known/unknown device and drug reactions/side effects at each follow-up visit. Safety assessment is defined as:• Local side effects o Redness, Itching, Burning, Blister formation, Oozing.
Intervention groups
1
Description
Treatment group: In this group, the skin lesion of patient along with 2 cm border of healthy skin around the lesion will be disinfected with antiseptic, followed by administration of local anesthesia with lignocaine. The skin lesion will then be exposed to thermal therapy((ThermoMed Model 1.8, Chemosurgery Inc. Phoenix-USA), to heat the affected area of the skin. The target temperature of 50°C willl be maintained for 30 seconds until whole lesion is covered. The area between the electrodes covers 49–73 mm2, therefore, several thermotherapy applications will be given to cover the whole lesion. From second visit onwards, the patients belonging to intervention group will be administered intralesional Meglumine (1.5gm/5ml equivalent to 81mg of antimony per 01 ml) 1-5ml mixed with 1:1 1% lidocaine, depending on lesion size but not exceeding 5 ml of total in one session.
Category
Treatment - Devices
2
Description
Control group: Meglumine intralesional injection will be given as first treatment session, followed by weekly sessions. Treatment sessions will be repeated on a weekly basis in the same manner for both the groups, where 4-6 sessions will be provided depending on the treatment response. Treatment responses will be assessed in both groups weekly until the treatment ends (maximum of 5 sessions) and follow-up visits at 8th week and 12th week post-treatment will be completed. Acute adverse reactions, adverse events and post-treatment adverse events will also recorded for both the groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Sector Clinic in endemic area Shakardara
Full name of responsible person
Nafisa Tahir
Street address
Naseer Uddin Clinic Shakardara
City
Shakardara KPK
Postal code
26380
Phone
+92 334 8331440
Email
dr.nafisa.tahir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
TDR/EMRO /WHO
Full name of responsible person
Nafisa Tahir
Street address
Jalan Teknokrat
City
Cyberjaya
Postal code
63000
Phone
+60 12-305 7700
Email
gsc-procurement@who.int
Grant name
SGS-20-21
Grant code / Reference number
2021-1088476-0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
TDR/EMRO /WHO
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Nafisa Tahir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Abid Majeed Road Rawalpindi
City
Islamabad
Province
Capital Territory
Postal code
44000
Phone
+92 51 9270175
Email
dr.nafisa.tahir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
National University of Medical Sciences
Full name of responsible person
Saleem Ahmed Khan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pathology
Street address
Abid Majeed Road
City
Islamabad
Province
Capital Territory
Postal code
44000
Phone
+92 51 9270677
Email
Director.RC@numpspak.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
National University of Medical sciences
Full name of responsible person
Fauzia Fatima Gilani
Position
Research Associate
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Abid Majeed Road
City
Islamabad
Province
Capital territory
Postal code
44000
Phone
+92 51 9270677
Email
fauziagilani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Results from the study in the form of tables and graphs of primary and secondary will be shared
When the data will become available and for how long
The data will be kept for 2 years. The results and findings of the study will be available in the form of publication. The data details can be shared with the journal on demand.
To whom data/document is available
Principal Investigator and co-investigator
Under which criteria data/document could be used
The data document can be shared with the publishing journal on demand
From where data/document is obtainable
Can contact the principal investigator.
What processes are involved for a request to access data/document
Principal investigator can be accessed through email.
dr.nafisa.tahir@gmail.com