| CTRI Number |
CTRI/2022/10/046393 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
10/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study on efficacy of CO2 laser and topical 2% clotrimazole daily application versus Nd: YAG laser and topical 2% clotrimazole daily application with lasers given at interval of 3 weeks to maximum of 6 sessions in treatment of onycomycosis |
|
Scientific Title of Study
|
A comparative study on efficacy of CO2 laser and topical 2% clotrimazole versus Nd: YAG laser and topical 2% clotrimazole in treatment of onycomycosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S NIVETHITHA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL |
| Address |
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
Department of DVL
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9486914293 |
| Fax |
|
| Email |
nivesekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S NIVETHITHA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL |
| Address |
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
Department of DVL
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9486914293 |
| Fax |
|
| Email |
nivesekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR R Sindhuja |
| Designation |
Associtae professor |
| Affiliation |
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL |
| Address |
Assistant professor quarters
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU
603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9842722883 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chengalpattu medical college and hospital
Chengalpattu
603001 |
|
|
Primary Sponsor
|
| Name |
Chengalpattu medical college and hospital |
| Address |
Department of DVL
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU,
603001 |
| Type of Sponsor |
Government medical college |
|
|
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 S NIVETHITHA |
Chengalpattu medical college and hospital |
OUT PATIENT DEPARTMENT DEPARTMENT OF DVL
CHENGALPATTU MEDICAL COLLEGE AND HOSPITAL,
CHENGALPATTU,603001
Kancheepuram
TAMIL NADU |
9486914293
nivesekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethical committee,chengalpattu medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Co2 |
CO2 laser 110mj/ cm2 along with topical 2% clotrimazole daily night application |
| Comparator Agent |
Nd:YAG |
Nd: YAG laser at dose of 750 mj/cm2 along with topical 2% clotrimazole |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
CLINICAL DIAGNOSIS OF ONYCOMYCOSIS |
|
| ExclusionCriteria |
| Details |
1.PREGNANT AND LACTATING WOMEN
2.PATIENTS WITH CHRONIC KIDNEY DISEASE,ON IMMUNOSUPPRESSUVE DRUGS. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of CO2 laser and topical 2% clotrimazole versus Nd: YAG laser and topical 2% clotrimazole in treatment of onycomycosis |
At baseline,6 week of treatment, 3 months after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety of CO2 laser and topical 2% clotrimazole versus Nd: YAG laser and topical 2% clotrimazole in treatment of onycomycosis |
At each session of treatment- 3 week ,6 week ,9 week ,12 week,15 week ,18 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not willing to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As oral antifungal require long duration of administration for onychomycosis newer mode of treatment like laser are being tried.So we would like to compare Two types of laser in treating onychomycosis |