Home » Trials » SLCTR/2013/024
Randomized, double blind, controlled, comparative clinical trial on efficacy and safety of intralesional 10% and 15% hypertonic saline vs sodium stiboglucate in cutaneous leishmaniasis
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SLCTR Registration Number
SLCTR/2013/024
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized, double blind, controlled, comparative clinical trial on efficacy and safety of intralesional 10% and 15% hypertonic saline vs sodium stiboglucate in cutaneous leishmaniasis
Public Title of Trial
Hypertonic saline in cutaneous leishmaniasis
Disease or Health Condition(s) Studied
Cutaneous leishmaniasis
Scientific Acronym
None
Public Acronym
None
Brief title
Hypertonic saline in cutaneous leishmaniasis
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/09-07 (Ethics Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
What is the efficacy and safety of 10% and 15% hypertonic saline in cutaneous leishmaniasis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Consenting patients will be randomized into three arms in 2: 2: 1 ratio considering the unwanted effects that may arise with 15% hypertonic saline. The first arm (A) will receive intralesional sodium stibogluconate (standard therapy), (B) will receive intralesional 10% hypertonic saline, (C) will receive intralesional 15% hypertonic saline.
Participants in arm A will receive between 1-7 intralesional injections, and participants in arms B and C will receive between 1-10 intralesional injections depending on response.
Inclusion criteria
All consenting patients presenting to the Skin Clinic, Teaching Hospital, Anuradhapura with a clinical diagnosis of cutaneous leishmaniasis, confirmed by slit-skin smear will be included.
Exclusion criteria
Primary outcome(s)
|
1.
Status of the skin lesion |
[ • Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] |
|
2.
Side effects at the site of the lesion due to the injections |
[ • Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] |
|
3.
Duration of treatment |
[ • Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] |
|
4.
Duration taken for cure |
[ • Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] |
|
5.
Clinical response: graded as slight (10% improvement), mild (30%), moderate (50%), marked improvement (70-80%) and total clearance of the lesion. Both marked improvements and total clearance will be considered as cure. |
[ • Weekly for the first to third injections • Every two weeks for the fourth and fifth injections • Monthly thereafter until the injections are complete (7 injections for arm A and 10 injections for arms B and C). ] |
Secondary outcome(s)
|
1.
Parasitological cure (negative slit skin smear) |
[ At the time of clinical cure ] |
Target number/sample size
250 (100, 100 and 50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-09-01
Anticipated end date
2014-08-30
Date of first enrollment
2013-08-08
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2009-12-04
Approval number
ERC/09-07
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Ranthilaka Ranawaka
Consultant Dermatologist
Base Hospital Homagama
Homagama
0718186148
ranthilaka37@yahoo.com
Contact Person for Public Queries
Ranthilaka Ranawaka
Consultant Dermatologist
Base Hospital Homagama
Homagama
0718186148
ranthilaka37@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
