TO STUDY EFFICACY OF MILTEFOSINE AND ALLOPURINOL IN COMBINATION VERSUS MILTEFOSINE ALONE IN CUTANEOUS LEISHMANIASIS
Design
Clinical trial which is parallel group, double blind, randomized, phase 3 trial
Settings and conduct
Dermatology Department, CMH Quetta
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients of both genders, aged 18-65 years with biopsy-proven cutaneous leishmaniasis.
Plus
• Positive LD bodies smear on Giemsa stain
• Lesions in sites not responding to local treatment or meeting WHO guidelines
• Multiple lesions on body
• Lesions on lower legs, over a joint, mucosa or cartilage
• Lesions located on sites not compatible with local treatment
• Lesions that are potentially disfiguring or disabling (i.e. on face, fingers or toes)
Exclusion criteria
• People with comorbidity(diabetes, hypertension, chronic liver diseases, chronic kidney disease) and or immunocompromised
• Allergy to Allopurinol,miltefosine and previous history of drug reactions to any drug.
• Has lesions that are limited in size (papules, nodules or ulcerated nodules)
• The lesion is already self-curing
• Patients enrolled in other research protocols
• Pregnant and breast feeding women
• Those who refused to accept the diagnostic procedures
• Children under 12 years of age
Intervention groups
Group A: Receives miltefosine (2.5 mg/kg) plus a placebo.(wt > 45 kg = 50 mg x TDS, < 45 kg 50mg x BID, max dose 150 mg /day) for 28 days.
Group B: Receives miltefosine and allopurinol (20mg/kg)
Main outcome variables
Clinical Response
General information
Reason for update
Acronym
CL Cutaneous Leishmaniasis
IRCT registration information
IRCT registration number:IRCT20210823052264N14
Registration date:2025-06-04, 1404/03/14
Registration timing:retrospective
Last update:2025-06-04, 1404/03/14
Update count:0
Registration date
2025-06-04, 1404/03/14
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-01, 1403/10/12
Expected recruitment end date
2025-06-30, 1404/04/09
Actual recruitment start date
2025-01-01, 1403/10/12
Actual recruitment end date
2025-05-31, 1404/03/10
Trial completion date
2025-07-01, 1404/04/10
Scientific title
EFFICACY OF MILTEFOSINE AND ALLOPURINOL IN COMBINATION VERSUS MILTEFOSINE ALONE IN CUTANEOUS LEISHMANIASIS
Public title
EFFICACY OF MILTEFOSINE AND ALLOPURINOL IN COMBINATION VERSUS MILTEFOSINE ALONE IN CUTANEOUS LEISHMANIASIS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both genders, aged 18-65 years with biopsy-proven cutaneous leishmaniasis.Plus
• Positive LD bodies smear on Giemsa stain
• Lesions in sites not responding to local treatment or meeting WHO guidelines
• Multiple lesions on body
• Lesions on lower legs, over a joint, mucosa or cartilage
• Lesions located on sites not compatible with local treatment
• Lesions that are potentially disfiguring or disabling (i.e. on face, fingers or toes)
Exclusion criteria:
• People with comorbidity(diabetes, hypertension, chronic liver diseases, chronic kidney disease) and or immunocompromised
• Allergy to Allopurinol,miltefosine and previous history of drug reactions to any drug.
• Has lesions that are limited in size (papules, nodules or ulcerated nodules)
• The lesion is already self-curing
• Patients enrolled in other research protocols
• Pregnant and breast feeding women
• Those who refused to accept the diagnostic procedures
• Children under 12 years of age
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
74
More than 1 sample in each individual
Number of samples in each individual:
0
empty
Actual sample size reached:
74
More than 1 sample in each individual
Actual sample size in each individual:
0
empty
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen.
before intervention and 2, 4 , 6 and 8 weeks after intervention until complete healing occur than patient called for follow-up after one month
Method of measurement
Clinical Response Evaluation
Secondary outcomes
1
Description
any side effects during leishmaniasis treament
Timepoint
2,4 ,6 ,8 weeks and 3 months after treatment
Method of measurement
interviewing with the patients and clinical examination
Intervention groups
1
Description
Intervention Group A: Receives miltefosine (2.5 mg/kg) plus a placebo.(wt > 45 kg = 50 mg x TDS, < 45 kg 50mg x BID, max dose 150 mg /day) for 28 days.
Category
Treatment - Drugs
2
Description
Intervention group: Group B: Receives miltefosine and allopurinol (20mg/kg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Quetta
Full name of responsible person
Dr Sammara Sarwar
Street address
Block D15 flat E Sarwar COLONY Quetta cantonment
City
Quetta
Postal code
08762
Phone
+92 340 0009994
Email
sammara.sarwar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Sammara Sarwar
Street address
Block D15 flat E Sarwar COLONY Quetta cantonment
City
Quetta
Postal code
08762
Phone
+92 340 0009994
Email
sammara.sarwar@gmail.com
Grant name
CMH Quetta
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
CMH QUETTA
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr sammara sarwar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Block D15 flat E Sarwar COLONY Quetta cantonment
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 340 0009994
Email
sammara.sarwar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr Sammara Sarwar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Block D15 flat E Sarwar COLONY Quetta cantonment
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 340 0009994
Email
sammara.sarwar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr sammara sarwar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Block D15 flat E Sarwar COLONY Quetta cantonment
City
Quetta
Province
Balochistan
Postal code
08762
Phone
+92 340 0009994
Email
sammara.sarwar@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
Yes - There is a plan to make this available
Title and more details about the data/document
Primary Outcome
When the data will become available and for how long
One month after publication
To whom data/document is available
People Working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
sammara.sarwar@gmail.com
What processes are involved for a request to access data/document