| CTRI Number |
CTRI/2020/08/027063 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
29/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study of 3 different dosages i.e Itraconazole 100mg vs 200mg vs 400mg or 5mg/kg whichever is lower in treatment of dermatophytosis (Ringworm) |
|
Scientific Title of Study
|
Itraconazole in the treatment of dermatophytosis : A comparison of 3 different dose regimens: A triple arm randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK C LACHURE |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE and SUM HOSPITAL |
| Address |
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar
Departement of Dermatology, venerology and Leprosy, Kalinga nagar,Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9309986054 |
| Fax |
|
| Email |
lachureabhishek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIKASH RANJAN KAR |
| Designation |
HOD & Professor |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE and SUM HOSPITAL |
| Address |
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar, Bhubaneswar
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9937428181 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
ABHISHEK C LACHURE |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE and SUM HOSPITAL |
| Address |
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar, Bhubaneswar
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9309986054 |
| Fax |
|
| Email |
lachureabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SOA university |
| Address |
K8, Kalinga nagar, bhubaneswar 751003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Lachure |
IMS and SUM hospital |
Departement of Dermatology, venerology and Leprosy, IMS and SUM Hospital, K8, kalinga nagar, Bhubaneswar
Khordha
ORISSA |
9309986054
lachureabhishek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Siksha 0 Anusandhan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 2 CAP twice daily or 5 mg/kg/day (restricted to 400mg) for 30 days |
| Comparator Agent |
Itraconazole |
Itraconazole 100 mg 2 CAP/day for 30 days |
| Intervention |
Itraconazole |
Itraconazole 100 mg/day for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All naive cases of dermatophytosis
2. Potassium hydroxide (KOH) positive cases
3. Treated cases but off treatment from
topical/systemic antifungal for the last
four weeks
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females.
2. History of diabetes.
3. Immunosuppressed patients.
4. Patient on drugs that interfere with
itraconazole metabolism
5. History of hepatic and renal impairment.
6. Cases of congestive heart failure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
KOH status
Culture status
Clinical clearance |
Outcome will be assessed after completion of study in june 2021. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety profile |
In terms of side effects of the drug at 4th week and 6th week |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
15/08/2020 |
| 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="2"
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
|
This study is a triple arm, open label, randomized control trial comparing the safety and efficacy of Itraconazole 100 mg vs 200 mg vs 400mg or 5 mg/kg whichever is lower in the treatment of dermatophytosis. This study will be conducted at IMS and SUM hospital, Bhubaneswar, India. The primary outcome measures will be KOH status, culture status, clinical clearance at 4th week and 6th week. The secondary outcome will be safety of the drug. |