| CTRI Number |
CTRI/2020/04/024710 [Registered on: 17/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE STUDY OF TWO DIFFERENT LASERS IN TREATMENT OF FUNGAL NAIL INFECTION |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF FRACTIONAL CO2 LASER VERSUS Q-SWITCHED ND-YAG LASER IN THE MANAGEMENT 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 |
DR DEVINDER SUHAG |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
COMMAND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
Bangalore
KARNATAKA
560007
India |
| Phone |
9650488406 |
| Fax |
|
| Email |
devindersuhag@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GP CAPT SANDEEP ARORA |
| Designation |
HEAD OF THE DERMATOLOGY DEPARTMENT |
| Affiliation |
COMMAND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
Bangalore
KARNATAKA
560007
India |
| Phone |
9910411635 |
| Fax |
|
| Email |
aroraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GP CAPT SANDEEP ARORA |
| Designation |
HEAD OF THE DERMATOLOGY DEPARTMENT |
| Affiliation |
COMMAND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
Koppal
KARNATAKA
560007
India |
| Phone |
9910411635 |
| Fax |
|
| Email |
aroraderma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
COMMAND HOSPITAL |
| Address |
DEPARTMENT OF DERMATOLOGY
COMMAND HOSPITAL, AIRFORCE
BANGALORE-560007 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DEVINDER KUMAR SUHAG |
COMMAND HOSPITAL |
DEPARTMENT OD DERMATOLOGY
COMMAND HOSPITAL,AIRFORCE
AGRAM POST,BANGALORE-560007
Bangalore
KARNATAKA |
9650488406
devindersuhag@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE COMMAND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L608||Other nail disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FRACTIONAL CO2 LASER IN ONE ARM AND Q SWITCHED ND YAG LASER IN SECOND ARM |
All the infected nails on one arm 2nd arm
Fractional CO2 laser :- Qs Nd-YAG
PE- 140 mj, PE - 1000mj
SD- 256 spots/cm2, fluence-1.2j/cm2
PI- 0.5 mm, PD- 0.1ms, and a PD - 6 ns
Rectangular spot size - 2 to 10 mm length
x 0.6 to 5 mm breadth.
3 passes will be given at the same site in static operating mode over the affected area including 1 mm normal-appearing areas around them. Altogether 4 sessions of laser therapy will be given, each at 4-week intervals |
| Intervention |
FRACTIONAL CO2 LASER ON ONE ARM AND Q SWITCHED ND YAG ON SECOND ARM |
a) Informed consent will be taken from individuals participating in the study.
b) All the cases will be assessed clinically for onychomycosis and objectively scored using “ONYCHOMYCOSIS SEVERITY INDEXâ€(OSI)(27) and further will be confirmed by nail clipping (KOH mount) and mycotic culture.
c) other shall be with Q Switch Nd-YAG LASER.
d) Pre-treatment- For topical anesthesia before laser therapy, EMLA (Lidocaine 7% w/w + Tetracaine 7% w/w) will be applied under occlusion on the infected nail and periungual area for 45 minutes.
e) All the infected nails on one arm will be treated with fractional CO2 laser using pulse energy of 140 mJ, energy density of 256 spots/cm2, pulse interval of 0.5 mm, pulse duration of 0.1 milliseconds, and a rectangular spot size of 2 to 10 mm length and 0.6 to 5 mm breadth. 3 passes will be given at the same site in static operating mode over the affected area including 1 mm normal-appearing areas around them. Altogether 4 sessions of laser therapy will be given, each at 4-week intervals.
f) All the infected nails on other arm will be treated with Q Switch Nd-YAG LASER laser using energy of 1000 mJ, fluence of 2.6J/cm2 and pulse duration of 6 ns. 3 passes will be given at the same site in static operating mode over the affected area including 1 mm normal-appearing areas around them after pairing the charred surface between the passes.
|
| Comparator Agent |
FRACTIONAL CO2 LASER ON ONE ARM AND Q SWITCHED ND YAG ON SECOND ARM |
All the infected nails on one arm 2nd arm Fractional CO2 laser :- Qs Nd-YAG PE- 140 mj, PE - 1000mj SD- 256 spots/cm2, fluence-1.2j/cm2 PI- 0.5 mm, PD- 0.1ms, and a PD - 6 ns Rectangular spot size - 2 to 10 mm length x 0.6 to 5 mm breadth. 3 passes will be given at the same site in static operating mode over the affected area including 1 mm normal-appearing areas around them. Altogether 4 sessions of laser therapy will be given, each at 4-week intervals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) All consecutive patients over the age of 18 years of either gender reporting to the department of Dermatology, CHAF Bangalore with one or more toenail and/or fingernail fungal infections of the following types: distal subungual onychomycosis, proximal subungual onychomycosis, superficial white or black onychomycosis, mixed patterns or total dystrophic type onychomycosis.
b) Diagnosis of Onychomycosis confirmed on demonstration of fungal hyphae on direct microscopy or fungal culture.
c) Subjects should be willing and able to comply with all follow-up requirements
d) Not on any medication for past 06 months for Onychomycosis.
|
|
| ExclusionCriteria |
| Details |
a) Cases where KOH mount for fungal hyphae and fungal culture are negative.
b) Patients who were on systemic or topical antifungals in the past three months.
c) Nail disorders due to psoriasis, chronic eczema, lichen planus, bacterial infections, subungual hematoma, and non-onychomycosis causes of nail dystrophy.
d) Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TREATMENT OF NAIL FUNGAL INFECTION-l) Follow-up shall be performed at each visit at 4 weeks interval with assessment of clinical improvement using OSI score, photography and patient subjective assessment score. In addition to the above modalities, assessment will be done with mycological cultures and KOH mount after 16 weeks and 6 months from initiation of treatment. Analysis of the data will be carried out at 6 months after initiation of treatment . |
After 6weeks and 6 month of 1st sitting of laser treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN QSI SCORE |
16 weeks and 6 months from initiation of treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| Date of Study Completion (India) |
08/07/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
study will be comparing the efficacy and side effect profile of Fractional CO2 LASER as compared to ,Nd-YAG LASER which is an accepted modality of treatment for onychomycosis.For the above study three passes of each laser will be given to two different diseased nail on each sitting , and result will be compared after 6weeks, and 16 weeks of treatment |