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CTRI Number  CTRI/2025/05/086402 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 05/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Fractional CO2 laser vs Nd -YAG laser with combination of topical anti fungal ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Different Types of Laser Treatments with Nail Paint for Fungal Nail Infections 
Scientific Title of Study   To study effectiveness of Fractional CO2 laser therapy combined with 8%Cicloprix Nail Lacquer versus Q switched Nd YAG laser combined with 8% Cicloprix Nail Lacquer in the treatment of Onychomycosis using a split side design within the same individual. A pilot study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ann Maria Paulose 
Designation  Dr, PG Student 
Affiliation  Institute of Naval Medicine, INHS Asvini, Mumbai 
Address  Dept of dermatology, 5th floor, INHS Asvini, Near RC Church, Colaba, Mumbai, Maharastra-400005

Mumbai
MAHARASHTRA
400005
India 
Phone  7769985778  
Fax    
Email  annmaria.p1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G R Rajput 
Designation  Associate professor, INHS Asvini 
Affiliation  Institute of Naval Medicine, INHS Asvini, Mumbai 
Address  Dept of dermatology, 5th floor, INHS Asvini, Near RC Church, Colaba, Mumbai, Maharastra-400005

Mumbai
MAHARASHTRA
400005
India 
Phone  7769985778  
Fax    
Email  asunilk22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ann Maria Paulose 
Designation  Dr, PG Student 
Affiliation  Institute of Naval Medicine, INHS Asvini, Mumbai 
Address  Dept of dermatology, 5th floor, INHS Asvini, Near RC Church, Colaba, Mumbai, Maharastra-400005


MAHARASHTRA
400005
India 
Phone  7769985778  
Fax    
Email  annmaria.p1995@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Institute of Naval Medicine, INHS Asvini, Mumbai 
Address  Institute of Naval Medicine, INHS Asvini Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ann Maria Paulose  Institute of Naval Medicine, INHS Asvini  Dept of dermatology, 5th floor, INHS Asvini, Near RC Church, Colaba, Mumbai, Maharastra-400005
Mumbai
MAHARASHTRA 		 07769985778

annmaria.p1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Naval Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fractional Co2 laser combined with 8% ciclopirox nail lacquer   One side of participant will receive treatment with fractional carbon dioxide (CO2) laser once every four weeks in conjunction with the topical application of 8% ciclopirox nail lacquer which will be applied once daiy for six days in a week 
Comparator Agent  Nd YAG laser combined with 8% ciclopirox nail lacquer  The comparator side will receive Q switched Nd YAG laser once every four weeks in conjunction with the topical application of 8 % ciclopirox nail lacquer six days a week. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  18 to 60 years of age
Positive KOH microscopy
Treatment naive patients
 
 
ExclusionCriteria 
Details  Age below 18 years and more than 60 years
In the case of female subjects, are pregnant, nursing or planning to become pregnant within the study period
Individuals with negative KOH mounts
Presence of other diseases causing nail dystrophy such as psoriasis, eczema, and lichen planus and immunodeficiency such as HIV infected patients, patients with organ transplantation and currently on immunosuppressive drugs for long periods or patients under chemotherapy or radiotherapy
Any significant disease of the hepatic, renal, endocrine including diabetes mellitus, immune systems, or other health conditions which could interfere with or confound the results of study assessments, pre existing chronic foot pain, neurologic deficit or skin disease or injury in treated foot 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
clinical efficacy and clinical cure rates of fractional CO2 laser therapy and Q switched Nd YAG laser therapy combined with 8% ciclopirox nail lacquer in reducing fungal nail infection symptoms.   04 months  
 
Secondary Outcome  
Outcome  TimePoints 
evaluate patient-reported outcomes including pain, discomfort, and cosmetic improvement.  04 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/05/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [annmaria.p1995@gmail.com].

  6. For how long will this data be available start date provided 20-07-2025 and end date provided 20-04-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Comparing Fractional CO2 laser vs Nd YAG laser in thetreatment of Onychomycosis along with topical 8% ciclopirox nail lacquer 
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