| CTRI Number |
CTRI/2019/05/019139 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
28/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [efficacy and tolerabitily of drug Itraconazole] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Itraconazole oral solution in Children with Fungal Infection |
|
Scientific Title of Study
|
The Efficacy and Tolerability of Itraconazole oral solution in Paediatric Dermatophytosis |
| Trial Acronym |
IPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Bhat M |
| Designation |
Professor, Dept. of Dermatology Venereology and Leprosy |
| Affiliation |
Father Muller Medical College |
| Address |
Professor
Dept of Dermatology, Venereology and Leprosy,
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9845084224 |
| Fax |
|
| Email |
rameshderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Bhat M |
| Designation |
Professor, Dept. of Dermatology Venereology and Leprosy, unit 2 |
| Affiliation |
Father Muller Medical College |
| Address |
Professor
Dept of Dermatology, Venereology and Leprosy,
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9845084224 |
| Fax |
|
| Email |
rameshderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Bhat M |
| Designation |
Professor, Dept. of Dermatology Venereology and Leprosy |
| Affiliation |
Father Muller Medical College |
| Address |
Professor
Dept of Dermatology, Venereology and Leprosy,
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9845084224 |
| Fax |
|
| Email |
rameshderma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil. investigator initiated project.
Dr Ramesh Bhat
Professor
Dept of Dermatology, Venereology and Leprosy,
Father Muller medical College, Kankanady, Mangalore |
|
|
Primary Sponsor
|
| Name |
Dr Ramesh Bhat M |
| Address |
Professor, Dermatology, Father Muller Medical College, Kankanady, Mangalore 2
Mangalore
|
| Type of Sponsor |
Other [investigator initiated project] |
|
|
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 Ramesh Bhat M |
Father Muller Medical College Hospital |
Dept of Dermatology, Venereology and Leprosy, Room no. 65
Dakshina Kannada
KARNATAKA |
9845084224
rameshderma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug |
Itraconazole Oral Solution
Dose 5mg/kg
Frequency Once daily
Oral administration
Duration 4 weks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients age group of 1to12 years with clinical diagnosis of cutaneous dermatophytosis in glabrous skin (Tinea faciei, Tinea corporis and Tinea Cruris).
Both boys and girls will be included in the study.
Patients /parents/guardians who are consenting to participate in the study.
Patients with recurrent and extensive (10% body surface area) Tinea infection will be taken for the study.
|
|
| ExclusionCriteria |
| Details |
• Patients with other pre-existing skin disorders.
• Patients/parents/guardians who are not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and Efficacy of Oral Itraconasole solution in Paediatric age group |
Two weeks and Four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerability and side effects of oral itraconazole solution |
2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2019 |
| Date of Study Completion (India) |
30/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Bhat M R, Satheesh D, Jayaraman J. Effectiveness, safety, and tolerability of itraconazole oral solution in pediatric dermatophytosis. Indian J Paediatr Dermatol 2020;21:259-63 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Purpose of Trial Presently dermatophytosis in India is resistant to treat and itraconazole is the widely used drug for the management considering the low response rate for previously used drugs like terbinafine, fluconazole and griseofulvin. Even though dermatophytosis in children is rare compared to adults, in the present epidemic it is seen in children also and the management of these recurrent and resistant dermatophytosis is a therapeutic challenge. Even though itraconazole in capsule form is widely used, it is difficult to administer it in children considering the size of the capsule. In view of the recent availability of itraconazole oral solution, this can be effectively administered with ease in children. However, there are only a few studies in the literature for the treatment of dermatophytosis with oral Itraconazole solution, hence this study is conducted. Itraconazole oral solution is efficacious and tolerable in Paediatric Dermatophytosis.
|