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CTRI Number  CTRI/2017/11/010471 [Registered on: 13/11/2017] Trial Registered Retrospectively
Last Modified On: 30/09/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the efficacy of isotretinoin and Terbinafine combination with Terbinafine alone in the treatment of recurrent fungal infections of the skin 
Scientific Title of Study   Evaluation Of Effectiveness Of Combination Of Isotretinoin With Terbinafine And Terbinafine Alone In The Treatment Of Recurrent Dermatophytosis: A randomised 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  Dr Gridharan senthilnathan 
Designation  Junior Resident - Academic 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Department of Dermatology and Venereology, AIIMS, New Delhi.

East
DELHI
110029
India 
Phone  9698747468  
Fax    
Email  sgdbio2009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrKaushalKVerma  
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Department of Dermatology and Venereology, AIIMS, New Delhi.

East
DELHI
110029
India 
Phone  01126593454  
Fax    
Email  prokverma@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gridharan senthilnathan 
Designation  Junior Resident - Academic 
Affiliation  All India Institute Of Medical Sciences, New Delhi 
Address  Department of Dermatology and Venereology, AIIMS, New Delhi.

East
DELHI
110029
India 
Phone  9698747468  
Fax    
Email  sgdbio2009@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology and venereology, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi. 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS, ANSARI NAGAR, NEW DELHI-110029 
Type of Sponsor  Research institution and hospital 
 
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 Gridharan Senthilnathan  All India Institute Of Medical Sciences   Room 4070 Office of The Department Of Dermatology And Venereology
East
DELHI 		 9698747468

sgdbio2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Recurrent Dermatophytosis Of Skin- Tinea Cruris and Corporis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  groupA- isotretinoin(0.5mg/kg) once daily and Terbinafine 250 mg twice daily for a period of 4 weeks. 
Comparator Agent  group B  Group B: terbinafine at 250 mg twice daiy for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients ≥ 18 years of age with tinea cruris and/or tinea corporis.
2) KOH (10%) positivity by microscopy from the lesion during the time of presentation.
3) Two or more episodes in one year.
4) Patients consenting to participate in the study. 
 
ExclusionCriteria 
Details  1) Not willing to consent and follow up for the study.
2) Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks.
3) Immunocompromised patients.
4) Patients with known active liver, cardiac, renal or neurological diseases or uncontrolled diabetes Mellitus.
5) Hypersensitivity to either isotretinoin or terbinafine.
6) Pregnant and lactating women.
7) Women desiring pregnancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cure rates of infection both clinically and microbiologiically in both the groups  After 4 weeks/ 6 weeks of treatment and after 3 months follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1) species identification
2) side effects of treatment 		 After 4 weeks/ 6 weeks of treatment and at 3 months follow up 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/01/2017 
Date of Study Completion (India) 30/07/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Dermatophytosis is the fungal  infection of superficial  layers of the skin, hairs and nail. They are the most common infectious condition presenting to the skin out patient department. The incidence of recuurent and chronic infections are increasing now a days and many a factors are being attributed to this increase.  Few include drug resistance, bio film formation, changing environmental and working conditions, reinfection from other family members.  The most common species being identified from the lesions are also showing a changing trend from T. rubrum to other less commoner species. The incidence in india is some where around 20% of general population. Hence there is a need for exploration of alternate therapeutic agents in the treatment of this condition.
recently a report was published in ijdvl, issue 5 about the use of oral isotretinoin in combination with itraconazole in the treatment of a single patient with recurrent dermatophytic infection and found to have complete cure in 4 weeks and no relapse was recorded in 6 months follow up. It was hypothesised that isotretinoin increased the epidermal turn over and lead to faster elimination of fungal spores from the skin, also tretinoin increased the skin pH and improved cell mediated immunity of the patient both of which were thought to help in the clearence of infection form the skin. hence, we plannned to conduct a study regarding the efficacy of isotretion in improving the clinical and microbiological cure rates in pateints with recurrent dermatophytosis.
After careful selction of patients and after obtaining informed written consent,  they will be evaluated clinically, microbiologically and by laboratory investigatons. fungal cultures and bio film formation from the positive cultures will also be done. Then they will be randomised in to one of the two groups A and B by means of simple randomisation by computer generated random numbers and treated accordingly. group A with isotretinoin (0.5mg/kg) and terbinafine 250 mg twice daily for 4 weeks. group B with terbinafine250 mg twice daily for 4 weeks. no blinding will be done. post treatment they will be evaluated by means of clinical, microbiological and laboratory means. the side effects of the treatment will also be looked for. the patients will be followed up for a period of 3 months to look for the relapse of the disease. the proportion of cure rates and relapse rates will be assessed by means of proportion test and the results will be considered significant at 5 % level of significance.
 
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