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CTRI Number  CTRI/2021/05/033344 [Registered on: 04/05/2021] Trial Registered Prospectively
Last Modified On: 03/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [CO2 laser]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between treatment of fungal infection of nail by laser and surgery 
Scientific Title of Study   Comparative evaluation of efficacy of ‘urea application followed by CO2 laser ablation’ and ‘nail avulsion’ as an adjuvant to conventional therapy 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  Dr Drishti Rajde 
Designation  1st year resident doctor 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD 35,GCS Medical College, Hospital and Research Centre, Opp DRM office, Naroda road

Ahmadabad
GUJARAT
380025
India 
Phone  9978926129  
Fax    
Email  drdrishtirajde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ranjan Raval 
Designation  Professor and HOD of Dept of Skin and V.D. 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD 35,GCS Medical College, Hospital and Research Centre, Opp DRM office, Naroda road

Ahmadabad
GUJARAT
380025
India 
Phone  9978926129  
Fax    
Email  ranjanmb@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Drishti Rajde 
Designation  1st year resident doctor 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD 35,GCS Medical College, Hospital and Research Centre, Opp DRM office, Naroda road

Ahmadabad
GUJARAT
380025
India 
Phone  9978926129  
Fax    
Email  drdrishtirajde@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  GCS Medical College Hospital and Research Centre 
Address  GCS Medical College, Hospital and Research Centre, opp DRM office, Naroda road, Saraspur 380025 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Drishti Rajde  GCS Medical College, Hospital and Research Centre  OPD-35, Dept of Dematology, Ground Floor, OPD area
Ahmadabad
GUJARAT 		 9978926129

drdrishtirajde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L608||Other nail disorders, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional therapy  Oral Itraconazole pulse therapy (200mg BD for 7 days per month) for 2-3 months for finger nails and for 3-4 months for toe nails. + Topical Amrolfine 5% nail lacquer once a week for 6 months for finger nails and for 9 months for toe nails.  
Intervention  Nail avulsion as an adjuvant to conventional therapy   The affected nail is avulsed. Then the patient is given oral Itraconazole pulse therapy (200mg BD for 7 days per month) for 2-3 months for finger nails and for 3-4 months for toe nails. + Topical Amrolfine cream for 6 months for finger nails and for 9 months for toe nails.  
Intervention  Urea application followed by CO2 laser ablation as an adjuvant to conventional therapy   Patient is given conventional therapy. Also, 10% preformulated urea cream is applied under occlusion followed by CO2 laser ablation of the affected nail. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Presence of fungus in nail clipping demonstrated by KOH/fungal culture
2) Dermoscopic findings suggestive of Onychomycosis
 
 
ExclusionCriteria 
Details  1) Individuals with photosensitive dermatoses
2) Individuals with contraindications to CO2 laser therapy like Isotretinoin use within the previous six months, history of keloid formation or hypertrophic scarring, ongoing ultraviolet exposure, prior radiation therapy to treatment area, collagen vascular disease
3) Individuals with deranged bleeding time, clotting time, PT, APTT
4) Individuals on antiplatelet therapy (Aspirin, clopidogrel, ticagrelor, etc)
5) Pregnant and lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Clinical cure rate by nail examination and photographic evaluation
2) Mycological cure rate by KOH microscopic examination
3) Change in OSI (onychomycosis severity index score)
 		 At baseline and at the end of 6 months (for finger nails) and 9 months (for toe nails)
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study adverse drug reactions due to topical and oral antifungal agents
2) To study post operative complications after nail avulsion
3) To study local complications after CO2 laser ablation
 		 Change in the above parameters at the end of 6 months in finger nails and 9 months in toe nails 
 
Target Sample Size   Total Sample Size="321"
Sample Size from India="321" 
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)   10/05/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Currently available treatment options for onychomycosis such as topical and systemic antifungals are often of limited efficacy, difficult to administer or associated with relevant side effects. The disease is notoriously difficult to treat due to the deep-seated nature of fungi within the nail plate, prolonged treatment requirements, poor patient adherence and frequent recurrences. Given the poor efficacy of currently available topical and systemic therapies, there is a renewed interest in exploring alternative treatment modalities for onychomycosis.
Aim of the current study is to compare the benefit of adding urea application followed by CO2 laser ablation and nail avulsion as an adjuvant to conventional therapy in treatment of onychomycosis.
 
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