FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/047953 [Registered on: 07/12/2022] Trial Registered Prospectively
Last Modified On: 01/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study Efficacy and safety of fractional CO2 laser with oral itraconazole SB versus oral itraconazole SB in treatment of onychomycosis among patients attending tertiary care hospital bhavnagar 
Scientific Title of Study   Efficacy and safety of fractional CO2 laser with oral superbioavailable itraconazole versus oral superbioavaible itraconazole in treatment of onychomycosis among patients attending tertiary care hospital bhavnagar- a randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khatri Dimple Nileshkumar 
Designation  Resident doctor 
Affiliation  Government Medical College, Bhavnagar 
Address  115 Skin opd,Sir T Hospital ,Jail road, bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9924741115  
Fax    
Email  dimplekhatri1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hita Mehta 
Designation  Head and Professor, Department of DVL Bhavnagar 
Affiliation  Government Medical College, Bhavnagar 
Address  115 Skin opd,Sir T Hospital ,Jail road, bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9429503188  
Fax    
Email  hitamehta88@gmail.com  
 
Details of Contact Person
Public Query  
Name  Khatri Dimple Nileshkumar 
Designation  Resident doctor 
Affiliation  Government Medical College, Bhavnagar 
Address  115 Skin opd,Sir T Hospital ,Jail road, bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9924741115  
Fax    
Email  dimplekhatri1997@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College,Bhavnagar 
 
Primary Sponsor  
Name  Khatri Dimple Nileshkumar 
Address  115 Skin opd,Sir T Hospital ,Jail road, bhavnagar 
Type of Sponsor  Other [SELF] 
 
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 
Khatri Dimple Nileshkumar  Sir T Hospital, Bhavnagar  115 Skin opd,Sir T Hospital ,Jail road, bhavnagar
Bhavnagar
GUJARAT 		 9924741115

dimplekhatri1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Government Medical College Bhavnagar  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  Super bioavailable itraconazole Galaxy fractional CO2 laser  Oral super bioavailable itraconazole 100mg twice a day for 7 days pulse therapy for 2 months Galaxy fractional CO2 laser- Laser therapy given at an interval of 4 weeks with deep mode,triple pass, pulse energy of 10-15mJ, a density of 10%,a pulse therapy of 0.5ms and pulse width of 0.5 -1.0 mm  
Comparator Agent  Super bioavailable itraconazole  Super bioavailable itraconazole- super bioavailable itraconazole 100mg twice a day for 7 days pulse therapy for 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients equal or more than 18 years of age, of either gender presenting with one or more finger nail onychomycosis.
 
 
ExclusionCriteria 
Details  Pregnant and lactating female
Patients with other nail disorders due to psoriasis ,chronic eczema ,lichen planus ,bacterial infection , subungual hematoma.
Patients who had used topical and systemic antifungal in the preceding 3 months.
Patients with SGOT and SGPT more than the normal range.
Patients with history of cardiac disease.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of fractional co2 laser with oral itraconazole SB in treatment of onychomycosis using Onychomycosis severity index


 		 at baseline, 4 weeks, 8 weeks and 12 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the side effects of fractional CO2 laser and oral Itraconazole SB in treatment of onychomycosis

 		 At baseline, 4 weeks , 8 weeks and 12 weeks.

 
 
Target Sample Size   Total Sample Size="326"
Sample Size from India="326" 
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)   15/12/2022 
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="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

   

Onychomycosis,a fungal infection of nail,is a refractory chronic infectious disease.

•It is the most common infectious disorder in adults accounting for upto 50% of all nail diseases.

•It does not only affect the appearance of affected nail but can also spread to other parts of the body and lead to complications such as cellulitis.

•Laser therapy for onychomycosis is a newer treatment modality.

•Using the principle of selective photothermolysis,lasers have a photothermal effect on fungi, with chitin augmenting the heating effect.

•Itraconazole is the first orally bioavailable triazole with broad spectrum antifungal action.

•Super bioavailable itraconazole has higher bioavailability than conventional itraconazole and targeted drug release.

•Dermoscopic pattern in onychomycosis shows jagged edges with longitudinal streaks and distal irregular termination.

•Traditional treatment of onychomycosis comprise of topical,oral,mechanical and chemical therapies.

•Oral super bioavailable itraconazole has low water solubility and high intestinal permeability which increases the bioavailabilty of the drug.

•Fractional CO2 laser with principal of selective photothermolysis can also aid in treatment of onychomycosis.

•There is paucity of study of CO2 laser in onychomycosis and this study will add to it.

Study Design : This study will be randomized comparative double arm study

Study Population : All the clinically diagnosed cases of onychomycosis coming to Dermatology OPD of Sir T Hospital, Bhavnagar from 1 July 2022 To 30 June 2023.

Study Duration : 15 months

Duration of Data Collection : 12 months

Sample size : Fractional  CO2 laser+Oral super bioavailable Itraconazole=163 nails

                           Oral super bioavailable Itraconazole=163 nails

Sampling method : Patients will be randomized in both the groups by using random number generator  after taking the consent according to the inclusion and exclusion criteria.

Inclusion criteria :

•Patients equal or more than 18 years of age, of either gender presenting with one or more finger nail onychomycosis.

•Exclusion criteria :

•Pregnant and lactating female

•Patients with other nail disorders due to psoriasis ,chronic eczema ,lichen planus ,bacterial infection , subungual hematoma.

•Patients who had used topical and systemic antifungal in the preceding 3 months.

•Patients with SGOT and SGPT more than the normal range.

•Patients with history of cardiac disease.

 

 
Close