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CTRI Number  CTRI/2018/02/012060 [Registered on: 21/02/2018] Trial Registered Prospectively
Last Modified On: 25/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of fungal infection of nail with LASER and its comparison with oral antifungal Itraconazole 
Scientific Title of Study   A comparative study of Fractional CO2 Laser with 1% Terbinafine cream versus Itraconazole 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  Eeshaan Ranjan 
Designation  Post graduate resident 
Affiliation  Command hospital Air Force 
Address  Department of Dermatology Command hospital Air Force Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9720639323  
Fax    
Email  eeshaan.ranjan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Eeshaan Ranjan 
Designation  Post graduate resident 
Affiliation  Command hospital Air Force 
Address  Department of Dermatology Command hospital Air Force Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9720639323  
Fax    
Email  eeshaan.ranjan@gmail.com  
 
Details of Contact Person
Public Query  
Name  S Radhakrishnan 
Designation  Professor & HOD 
Affiliation  Command hospital Air Force 
Address  Dept. of Dermatology Command hospital Air Force Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9720639323  
Fax    
Email  drsrkskin@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology Command hospital Air Force Bangalore-560007 Karnataka  
 
Primary Sponsor  
Name  Command hospital Air Force Bangalore 
Address  Department of Dermatology Command hospital Air Force Bangalore-560007 Karnataka 
Type of Sponsor  Government 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 
Eeshaan Ranjan  Dermatology OPD  Dept. of Dermatology Command hospital Air Force Bangalore-07
Bangalore
KARNATAKA 		 9720639323

eeshaan.ranjan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Onychomycosis, (1) ICD-10 Condition: L608||Other nail disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fractional CO2 Laser and topical Terbinafine cream  50 Onychomycosis patients, Fractional CO2 Laser would be done at monthly intervals for four months in patients with Onychomycosis. They will also apply topical Terbinafine cream twice daily for four months. 
Comparator Agent  Oral Itraconazole capsule  50 Onychomycosis patients, pulse therapy with capsule Itraconazole 200 mg twice a day for 1 week every month, for three months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Males and females over the age of 18 years
2.Patient 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.
3.Confirm diagnosis using fungal culture and direct microscopy. 
 
ExclusionCriteria 
Details  1.Fungal culture negative or no evidence on direct microscopy.
2.Those patients who used systemic or topical antifungal in the past three months.
3.Conditions like bacterial infections, subungual hematoma, associated nail disorders which produce changes in the nail plate like psoriasis, atopic dermatitis, lichen planus.
4.Pregnant women. 
 
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 
Reduction in Onychomycosis Severity Index or complete clearance  6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Onychomycosis Severity Index or complete clearance  AT 3, 4 AND 5 MONTHS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) Date Missing 
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    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Onychomycosis is a fungal infection of the nail apparatus. It can involve either toenails or fingernails. Onychomycosis causes pain, discomfort, and disfigurement and the discoloration of nails which is the most common complaint and may produce serious physical and occupational limitations, as well as affect the quality of life. Different treatment options are available to treat nail onychomycosis including multiple systemic and topical antifungal agents or surgical nail removal. Long treatment regimens with incomplete cure are some disadvantages of the current treatment options. Newer techniques like photodynamic therapy and Fractional CO2 lasers are showing promising results.

 

This study will be comparing the efficacy and side effect profile of Fractional CO2 LASER as compared to oral Itraconazole.

 

Material and methods

 

1. Source of data

a) Study design: Prospective, randomized, interventional study

b) Cases: All consecutive patients presenting with onychomycosis at dermatology department of Command Hospital (Air Force) Bangalore during the study period reporting to Dermatology department of CHAF Bangalore

c) Duration of study: 18 months 

d) Sample size: 100 patients (50 patients in each arm).

 

2. Inclusion criteria

a) All consecutive patients over the age of 18 years of either gender reporting with one or more toenail and/or fingernail fungal infections

b) Diagnosis of Onychomycosis confirmed on demonstration of fungal hyphae on direct microscopy and fungal culture.

c) Subjects should be willing and able to comply with all follow-up requirements

 

3. Exclusion criteria

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 other non-onychomycosis causes of nail dystrophy

d) Pregnant and lactating women

 

4. Intervention

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 INDEX(OSI) and further will be confirmed by nail clipping (KOH mount) and mycotic culture.

 

c) Only culture positive cases shall be included in the study.

 

d) The patients shall be randomized through draw of cards and allocated to either study arm. One study arm shall include treatment with Fractional CO2 LASER intermittently along with topical application of 1% Terbinafine cream and the other shall be administered Capsule Itraconazole.

 

e) 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.

 

f) All the infected nails will be treated with fractional CO2 laser using pulse energy of 110 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. Topical 1% Terbinafine cream will then be applied to the affected nails twice daily.

 

g) Itraconazole shall be administered in the dose of 200mg twice daily for one week per month for 3 months.

 

h) 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 12 weeks and 6 months from initiation of treatment. Analysis of the data will be carried out at 6 months.

 

i) All participants will be asked to complete "subjective assessment score" rating their level of satisfaction

 

j) Complete cure is accepted as the combination of both mycological and clinical cure.

 

k) Instructions

            - Should not apply moisturizer or any other anti-fungal cream.

            - Should not take any oral antifungal drug.

            - Regular follow-up for the treatments

 

l) The data will be maintained prospectively in a computerized database, along with hard copies of proformas which will be analyzed using appropriate statistical techniques.

 

m) Side effects, if any due to Fractional CO2 LASER or with oral Itraconazole will be monitored. Signs and symptoms like, erythema, and Vesicular eruptions, Fissures, itching or burning will be followed up every week for 12 weeks. Liver function tests will be done every month in patients taking Itraconazole.

 

 


 
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