| CTRI Number |
CTRI/2017/08/009375 [Registered on: 16/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Q Switched Nd:Yag laser] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of Laser versus oral medicine (Itraconazole) in treatment of fungal infection of the nails. |
|
Scientific Title of Study
|
A study of Q-switched Nd:Yag laser in treatment of onychomycosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Arora |
| Designation |
Senior Advisor, Professor |
| Affiliation |
Armed Forces Medical Services, India |
| Address |
Skin Department
Base Hospital
Delhi Cantonment
South West
DELHI
110010
India |
| Phone |
9910411635 |
| Fax |
|
| Email |
aroraderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Arora |
| Designation |
Senior Advisor, Professor |
| Affiliation |
Armed Forces Medical Services, India |
| Address |
Skin Department
Base Hospital
Delhi Cantonment
South West
DELHI
110010
India |
| Phone |
9910411635 |
| Fax |
|
| Email |
aroraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Khandpal |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical Services, India |
| Address |
Skin Department
Base Hospital
Delhi Cantonment
South West
DELHI
110010
India |
| Phone |
|
| Fax |
|
| Email |
Renuk33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Base Hospital Delhi Cantt,
Delhi 110010 |
|
|
Primary Sponsor
|
| Name |
Base Hospital Delhi Cantt |
| Address |
Base Hospital Delhi Cantt
Pin: 110010 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Arora |
Base Hospital Delhi Cantt |
Department of Dermatology
South West
DELHI |
9910411635
aroraderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Base Hospital Delhi Cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Onychomycosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr. Renu Khandpal |
Resident (Dermatology)
Base Hospital Delhi Cant 110010 |
| Comparator Agent |
Dr. Sandeep Arora |
Senior Advisor & Professor
Base Hospital Delhi Cantt 110010 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed diagnosis of Onychomycosis in either fungal culture or direct microscopy
2. No history of past treatment |
|
| ExclusionCriteria |
| Details |
1. Fungal culture negative/failure to demonstrate fungus on nail KOH mount
2. Periungual bacterial infections, subungual hematoma
3. Associated nail disorders which produce changes in the nail plate like psoriasis, pityriasis rubra pilaris, atopic dermatitis and lichen planus
4. Pregnant women
5. Deranged liver functions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nail clearance 3mm in 12 weeks |
0,3 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onychomycosis severity Index |
0, 3 months, 12 months |
| Visual Analogue Scale |
0,3 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/07/2015 |
| Date of Study Completion (India) |
26/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Onychomycosis, worldwide in distribution accounts for approximately 20-40% percent of all nail disorders. Individuals wearing shoes for prolonged durations, those with co morbidities
like diabetes, peripheral vascular disease, HIV, immunosuppression are more
prone to this infection. Further it serves as a source of infection to self
or others and affects the quality of life by causing disfigurement of the nail,
pain and discomfort, physical and occupational limitations resulting in negative
effect on the social, emotional and occupational functioning of the individual
and in severe cases may even lead to depression. Slow growth of the nail along with increasing resistance to anti fungal drugs makes definitive treatment of this condition challenging. Options include debridement
of nail; mechanical and chemical palliative care, oral and topical antifungal
drugs, and their various combinations. Choice of treatment depends upon the
disease severity but is subject to relatively high failure rates, is time consuming
and costly. The cure rate is only 40-80% even after several months
of use of potent systemic antifungals which is worse in face of increasing
dermatophyte resistance. Oral medications may be associated
with side effects like vomiting, constipation, headache, drowsiness and skin
rash. Q switched Nd:Yag laser is now approved for management of onychomycosis, however conflicting reports exist in literature about its efficacy. No reports from India exist in such management.
This study was hence conducted with the aim to study
the efficacy of Q Switched Nd Yag laser management of onychomycosis in comparison to
Itraconazole which is also approved for dermatophyte onychomycosis and is used as an off-label
indication for non-dermatophyte onychomycosis. The study was initiated with a Null hypothesis that Q switched Nd Yag Laser is not as effective as capsule Itraconazole in management of onychomycosis. |