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Comparative efficacy of low dose oral dapsone and intralesional meglumine antimoniate with  intralesional meglumine antimoniate in patients presenting with cutaneous leishmaniasis.

Protocol summary

Study aim
The objective of this study to compare the efficacy of dapsone and intralesional meglumine antimoniate with intralesional meglumine antimoniate in patients presenting with Cutaneous leishmaniasis.the study aims to show complete response; complete re-epithelialization, disappearance of edema, induration, lesions becoming flatter and turning from erythematous to residual hyperpigmentation in colour assessed on photograph and clinical examination.
Design
Community-based ,parallel , non blind , randomized controlled trial
Settings and conduct
This study will be conducted on patients presenting in Dermatology OPD fulfilling the inclusion criteria , Study is Not blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients between 16-60 years of age, patients with positive smear or skin biopsies for amastigotes, lesions four or less in number and no lesion more than 4cm in size. ·       Either gender ·       Willing to provide informed consent. Exclusion Criteria: Pregnant or lactating women, sporotrichoid spread, use of any anti-leishmania treatment in the past 3 months, lesions at sites that merit systemic antimonials, allergy to antimonials and patients with history of liver disease, patient having G6PD deficiency will be excluded from the study .
Intervention groups
Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate.co
Main outcome variables
Showing complete response; complete re-epithelialization, disappearance of edema, induration, lesions becoming flatter and turning from erythematous to residual hyperpigmentation in colour assessed on photograph and clinical examination.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241028063523N3
Registration date: 2024-11-25, 1403/09/05
Registration timing: registered_while_recruiting

Last update: 2024-11-25, 1403/09/05
Update count: 0
Registration date
2024-11-25, 1403/09/05
Registrant information
Name
Atiya Rahman
Name of organization / entity
Bahria University of Health Sciences Campus Karachi Pakistan
Country
Pakistan
Phone
+92 21 35319491
Email address
atiyarahman.bumdc@bahria.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of low dose oral dapsone and intralesional meglumine antimoniate with  intralesional meglumine antimoniate in patients presenting with cutaneous leishmaniasis.
Public title
Comparative efficacy of low dose oral dapsone and intralesional meglumine antimoniate with  intralesional meglumine antimoniate in patients presenting with cutaneous leishmaniasis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
·Patients between 16-60 years of age, patients with positive smear or skin biopsies for amastigotes, lesions four or less in number and no lesion more than 4cm in size.·       Either gender· Willing to provide informed consent.
Exclusion criteria:
Pregnant or lactating women, sporotrichoid spread, use of any anti-leishmania treatment in the past 3 months, lesions at sites that merit systemic antimonials, allergy to antimonials and patients with history of liver disease,patient having G6PD deficiency will be  excluded from the study
Age
From 16 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
All patients presenting in the OPD of the Dermatology Department of PNS Shifa fulfilling the inclusion criteria will be included in this study. Written informed consent from the participants will be taken. Patients will be divided into two groups using lottery method. Demographic details which include age, weight, BMI, duration of disease, size , site and no. of lesions and gender will be noted and will be recorded on the approved performa. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate. Participants will be treated for 16 weeks or earlier if has occurred, whatever will be happened earlier. They will be evaluated in the 4th, 8th, 12th, 16th weeks of the treatment for efficacy.
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
Ethical committee PNS SHIFA
Street address
PNS Shifa Hospital, Sailor street DHA phase ll , near Kala pul
City
Karachi
Postal code
07557
Approval date
2024-11-18, 1403/08/28
Ethics committee reference number
ERC/2024/Derma/124

Health conditions studied

1

Description of health condition studied
Cutaneous leishmaniasis is caused by an “intracellular parasite” that is transferred to humans by a sand fly bite. It is endemic throughout Asia, Africa, Mediterranean region and America. It is estimated that there are between 0.7 to 1.2 million new cases of CL per year worldwide. It is a neglected third commonest vector borne disease in the world. It is widely spread in different parts of the world including South and Central America, Mediterranean Basin, Middle East and Central Asia.Leishmania tropicalis has a common association with the late ulcerative or dry urban type. The L. major causes the “wet, rural, or early” ulcerative type, which is characterized by many, eg’ often healing ulcers within a year. Mucocutaneous leishmaniasis, leishmaniasis recidivans, and diffuse cutaneous leishmaniasis are the rarest types of the disease .
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Efficacy will be labeled if patients with CL lesion in either group showed complete response; complete re-epithelialization, disappearance of edema, induration, lesions becoming flatter and turning from erythematous to residual hyperpigmentation in colour assessed on photograph and clinical examination.
Timepoint
Patient will be assessed before intervention and 4th ,8th , 12th , 16th weeks after intervention
Method of measurement
Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis.

Secondary outcomes

1

Description
Side effects: Monitoring and documenting adverse effects related to the treatment, such as hemolysis, methemoglobinemia, peripheral neuropathy, allergic dermatitis, headache,
Timepoint
4th, 8th, 12th, 16th weeks
Method of measurement
Patients having a typical, non-healing, painless, indurated papule, nodule, or plaque with or without crust on clinical assessment will labeled as having cutaneous leishmaniasis and will be confirmed by a direct smear taken from the lesions, which will then be stained with Giemsa stain showing Leishman bodies (amastigotes) on microscopic examination. , Skin biopsy to be done if required to confirm diagnosis.

Intervention groups

1

Description
Intervention group: Confirmed cases of cutaneous leishmaniasis will be divided into 02 groups .Group-A and Group-B. Group-A will receive intralesional meglumine antimoniate weekly and Group-B will receive oral dapsone (initially 25 mg/day for 01 week then 50mg/day onwards) with monitoring of Blood CP and Liver function tests and weekly intralesional meglumine antimoniate.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
PNS SHIFA HOSPITAL
Full name of responsible person
Jotee Rani
Street address
Pns Shifa Hospital, sailors street DHA Phase 2 , main korangi road near kalapul Karachi
City
Karachi
Postal code
07557
Phone
+92 21 48506540
Email
jotyrani321@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Armed forces Hospital PNS Shifa Hospital Karachi, Pakistan
Full name of responsible person
Dr Jotee Rani
Street address
Sailor street , DHA phase II , PNS SHIFA HOSPITAL near Kala pul
City
Karachi
Postal code
07557
Phone
+92 21 48506540
Email
jotyrani321@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed forces Hospital PNS Shifa Hospital Karachi, Pakistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Armed forces Hospital , PNS SHIFA
Full name of responsible person
Dr ATIYA RAHMAN
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sailor street, DHA PHASE II, PNS SHIFA HOSPITAL NEAR KALA PUL
City
Karachi
Province
Sindh
Postal code
07557
Phone
+92 21 48506540
Email
jotyrani321@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Armed forces Hospital PNS SHIFA Karachi , Pakistan
Full name of responsible person
Dr Atiya Rahman
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sailor street , DHA phase II, PNS SHIFA HOSPITAL near Kala pul.
City
Karachi
Province
Sindh
Postal code
07557
Phone
+92 21 48506540
Email
jotyrani321@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Armed forces Hospital PNS SHIFA Karachi, Pakistan.
Full name of responsible person
Dr Jotee Rani
Position
Post graduate resident
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
Sailor Street DHA phase II, PNS SHIFA Hospital near Kala pul.
City
Karachi
Province
Sindh
Postal code
07557
Phone
+92 21 48506540
Email
jotyrani321@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
APPENDIX 1: PROFORMA COMPARATIVE EFFICACY OF LOW DOSE ORAL DAPSONE AND INTRALESIONAL MEGLUMINE ANTIMONIATE WITH  INTRALESIONAL MEGLUMINE ANTIMONIATE IN PATIENTS PRESENTING WITH CUTANEOUS LEISHMANIASIS– A RANDOMIZED CONTROLLED TRIAL Name:   _______________________________              Age (years):  ___________________ Weight (kg): ____________________ BMI (kg/m2): __________________________              Duration (weeks) : _______________ Gender: Male/Female Size of lesion: Site of lesion: No. of lesion: Site: ·       Trunk ·       Arm ·       Hand ·       Leg ·       Feet Group: A ( I/L meglumine antimoniate weekly) Group : B ( Oral dapsone 50 mg/day and weekly I/L meglumine antimoniate) OUTCOME VARIABLE: EFFICACY: YES/NO
When the data will become available and for how long
After 6 months RCT , for 4 years
To whom data/document is available
Primary investigator
Under which criteria data/document could be used
All patients in Dermatology OPD according to operational definition of cutaneous leishmaniasis fulling the inclusion criteria
From where data/document is obtainable
Administration of PNS SHIFA HOSPITAL
What processes are involved for a request to access data/document
Contact to primary investigator
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