Home » Trials » SLCTR/2013/013
Randomized, double blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy in the treatment of non-dermatophyte onychomycosis
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SLCTR Registration Number
SLCTR/2013/013
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized, double blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy in the treatment of non-dermatophyte onychomycosis
Public Title of Trial
Treatment for fungal infection of nails
Disease or Health Condition(s) Studied
Non-dermatophyte onychomycosis
Scientific Acronym
None
Public Acronym
None
Brief title
Use of itraconazole and terbinafine pulse therapy in NDM onychomycosis
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/12-006 (Ethics Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
What is the efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy in the treatment of non-dermatophyte onychomycosis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Consenting patients will be randomized into two arms. The first arm (A) will receive oral Itraconazole pulse therapy (i.e. itraconazole 200 mg twice daily for 7 days per month; 1 week on and 3 weeks off). Two pulses will be given for fingernail infections and three pulses for toenail infections. The second arm (B) will receive Terbinafine pulse therapy: terbinafine 250mg twice daily for 7 days per month; 1 week on and 3 weeks off). Two pulses will be given for fingernail infections and three pulses for toenail infections
Inclusion criteria
All patients with non-dermatophyte mycology as confirmed by fungal studies will be recruited
Exclusion criteria
Primary outcome(s)
|
1.
Clinical cure (morphologically normal nail) |
[ At 12 weeks for fingernail infections and 16 weeks for toenail infections ] |
|
2.
Mycological cure (negative light microscopic examination [KOH] and negative fungal culture) |
[ At 12 weeks for fingernail infections and 16 weeks for toenail infections ] |
Secondary outcome(s)
|
1.
Long term clinical cure (morphologically normal nail) |
[ For fingernail infections: every 12 weeks for a total 14 months For toenail infections: every 12 weeks for a total 15 months ] |
|
2.
Long term Mycological cure (negative light microscopic examination [KOH] and negative fungal culture) |
[ For fingernail infections: every 12 weeks for a total 14 months For toenail infections: every 12 weeks for a total 15 months ] |
Target number/sample size
100 (50 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-05-01
Anticipated end date
2015-04-30
Date of first enrollment
2013-03-28
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2012-06-15
Approval number
ERC/12-006
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.
0718186148
ranthilaka37@yahoo.com
Contact Person for Public Queries
Ranthilaka Ranawaka
Consultant Dermatologist
Base Hospital Homagama.
0718186148
ranthilaka37@yahoo.com
Primary study sponsor/organization
Base Hospital Homagama
01128555200,0115059646
www.homagamahospital.org
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
