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CTRI Number  CTRI/2019/12/022283 [Registered on: 10/12/2019] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation the efficacy & safety of increased dose & duration of oral itraconazole therapy in recurrent tinea corporis et cruris of skin : a pilot study 
Scientific Title of Study   Efficacy and safety of increased dose and duration of oral Itraconazole therapy in recurrent tinea corporis et cruris – a comparative study 
Trial Acronym  ITRA KIMS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jnana Ranjan Dash 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Dermatology Venereology and Leprosy KIMS, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9861102483  
Fax    
Email  jrdash17462@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jnana Ranjan Dash 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Dermatology Venereology and Leprosy KIMS, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9861102483  
Fax    
Email  jrdash17462@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jnana Ranjan Dash 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Dermatology Venereology and Leprosy KIMS, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9861102483  
Fax    
Email  jrdash17462@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Dr Jnana Ranjan Dash 
Address  Dr. JNANA RANJAN DASH Asst.Professor Dept. of Dermatology Venereology and Leprosy KIMS, Bhubaneswar Pin 751024  
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 
Dr Jnana Ranjan Dash  Kalinga Institute of Medical Sciences Bhubaneswar  Department of Dermatology Venerology and Leprosy Kalinga Institute of Medical Sciences Bhubaneswar
Khordha
ORISSA 		 9861102483

jrdash17462@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kalinga Institute of Medical Sciences, Bhubaneswar  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 
Comparator Agent  Itraconazole   Itraconazole 100 mg twice daily per oral for 4 weeks 
Intervention  Itraconazole  Itraconazole 200 mg twice daily per oral for 12 weeks 
Intervention  Itraconazole  Itraconazole 200 mg twice daily per oral for 4 weeks 
Intervention  Itraconazole  Itraconazole 200 mg twice daily per oral for 8 weeks 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either gender with body weight ≥40 kg diagnosed with Tinea corporis & tinea cruris who are poor responders to the standard dosage regimen (100mg. of oral Itraconazole therapy for 4 wks twice daily.)
2. Patients of Tinea corporis & tinea cruris with frequent relapses after taking standard dosage regimens of oral Itraconazole for more than 6 months.
3. Female Patients of reproductive age group willing to follow contraceptive procedures during the study period.
 
 
ExclusionCriteria 
Details  1. Patient less than 12 years and more than 70 years of age/ less than 40 kg. body weight.
2. Patient with any immunocompromised medical status viz. Diabetes Mellitus, HIV Infection, Immunosuppressive therapy.
3. Patient suffering from any other illness like Congestive Cardiac failure and chronic kidney disease and patients with elevated liver enzymes (more than 2 times of upper limit of normal)
4. Patients taking drugs viz. rifampicin, phenytion, digoxin, anticoagulants, terfenadine, diseases which are contraindicated with itraconazole as co-therapy.
4. Any Oral or Topical Antifungal Therapy within 1 month of before the start of treatment trial
5. Patients who are not capable enough to bear the cost of treatment & investigations ,not cooperative enough to come for follow up.
6. Pregnancy and Lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Mycological cure in group A,B and C.
2.Clinical Cure: Improvement in Clinical Signs and Symptoms Investigator’s assessment to be rated on a 4-Point scale .Treatment Efficacy is measured by the Investigator using a 4-Point scale
3.Safety of Treatment- Any adverse drug reactions will be noted at each visit.
It will be assessed by recording Investigator’s &Patient’s assessment of tolerability. 		 every two weeks for 4 weeks , 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Rate of relapse after completion of study period in each group.  twelve weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results of the study will be published after completion of the study. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
BACKGROUND:Currently, dermatologists across India are inundated with cases of dermatophytosis presenting with unusual large lesions, ring within ring lesions, multiple site lesions (tinea cruris et corporis), and corticosteroid modified lesions, making diagnosis a difficult bet .In addition, chronicity of the disease has plagued the patients unlike any other dermatological condition in the country .The American Academy of Dermatology guidelines on the management of tinea cruris and corporis were published two decades ago. Also, the treatment recommendations in the standard textbooks of dermatology appear to have lost their relevance in the current clinical scenario . Thus, the management of dermatophytosis in India is in need of an evidence-based, experience-driven, practical approach from the experts in the field .The existing evidence is primarily based on observational cohort studies rather than randomized controlled trials (RCT). Properly designed RCTs are required to address these need gaps. There are published guidelines on tinea capitis and unguium . However, these are not  applicable for the treatment of other dermatophytosis, like tinea corporis, cruris and pedis, in the current scenario in India.Failure to get a satisfactory clinical outcome with the Standard Dosage Regimens(5mg./kg./day,with maximum of 200mg./day) of Oral Itraconazole Therapy for 4weeks. compelled us to try out the Increased Dosage Regimen (10mg./kg./day,with  maximum. of 400mg./day)for longer duration of treatment.
OBJECTIVES: To evaluate the efficacy and safety of increased dose and duration of itraconazole in recurrent tinea corporis and tinea cruris.
METHODS: A single centre hospital based three arm, pilot randomized open label trial is planned in accordance with the declaration of Helsinki protocols. All patients will be selected based on their eligibility criteria after obtaining written informed consent to participate in the study. The study will be conducted at the Department of Dermatology, Venereology & Leprology outpatient department of Kalinga Institute of Medical Sciences, Bhubaneswar. The study duration will be one year. All the eligible patients will be randomly allocated in to three groups.Group A patients will receive oral itraconazole 400mg per day for 4weeks, group B patients will receive  itraconazole 400mg per day for 8weeks.Group C patients will receive itraconazole 400mg per day for 12 weeks duration. Clinical and mycological cure rates in the three groups will be evaluated. Relapse rate in the three groups will be assessed up to 12 weeks after treatment.Adverse drug reactions if any will be recorded and monitored.

SAMPLE SIZE:  Total 120 eligible patients will be divided in to three groups.

 
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