| CTRI Number |
CTRI/2025/08/093154 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two types of itraconazole for the treatment of fungal skin infection |
|
Scientific Title of Study
|
Comparative study of efficacy and safety of Superbioavailable Itraconazole(SBITZ130) and conventional Itraconazole(CITZ 200) in patients with dermatophytosis in a tertiary care hospital: A Randomized control 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 Anu Gupta |
| Designation |
Professor |
| Affiliation |
Adesh University |
| Address |
Department of Dermatology
Adesh Institute of Medical sciences and Research Bhucho Khurd Bathinda
Barnala Road, Bhucho
Bathinda
PUNJAB
151101
India |
| Phone |
9872401332 |
| Fax |
|
| Email |
mandeepelahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep Kaur |
| Designation |
Professor |
| Affiliation |
Adesh University |
| Address |
B 307
Adesh Institute of Medical sciences and research Bhucho Khurd Bathinda
Barnala Road Bhucho
Bathinda
PUNJAB
151101
India |
| Phone |
09888083526 |
| Fax |
|
| Email |
mandeeparzoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep Kaur |
| Designation |
Professor |
| Affiliation |
Adesh University |
| Address |
Department of Pharmacology Adesh Institute of medical Sciences and research Bhucho Khurd Bathinda
Barnala Road, Bhucho
Bathinda
PUNJAB
151101
India |
| Phone |
01645055098 |
| Fax |
|
| Email |
mandeepelahi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of Medical Sciences and Research Bhucho Khurd Bathinda Punjab India 151101 |
|
|
Primary Sponsor
|
| Name |
Dr Anu Gupta |
| Address |
Department of Dermatology Adesh Institute and Medical sciences and research Bhucho Khurd Bathinda Punjab India 151101 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Anu Gupta |
Adesh Hospital Attached to Adesh Institute of medical sciences and research Bathinda |
Department of Dermatology Adesh University NH-7
Barnala Road Bhucho Kurd Bathinda Punjab India
Bathinda
PUNJAB |
09872401332
mandeepelahi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University Bathinda |
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 |
Conventional preparation of Itraconazole(CITZ 200) |
CITZ 200 mg OD oral for 6 weeks |
| Intervention |
Super Bioavaialble Itraconazole(SBITZ) |
SBITZ 130 mg OD oral for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinical diagnosis of dermatophytosis confirmed by direct microscopic examination of skin scrapings from the active border of the lesion after adding a drop of 10 percent potassium hydroxide solution
2 Had no prior history of using an oral antifungal in the previous four or a topical antifungal/steroid in the prior two weeks
3 Patient willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Patients with extensive dermatophytosis, other forms of tinea infections, superadded bacterial infection
2 Patients taking concomitant medications that interact with itraconazole
3 Immuno-compromised patients and patients with co-morbid conditions like diabetes, CHF and liver dysfunction
4 Pregnant and lactating females
5 Patients with a history of hypersensitivity to azole antifungals
6 Patients who may require other antifungal drugs during the study period due to any other cause will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients achieving complete cure (clinical + mycological) at end of treatment, assessed by Lesion Severity Score (LSS) and Area Severity Score (ASS). |
Clinical Assessment at 2, 4 and 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recurrence of dermatophytosis
|
assessed at the end of 10th week |
| Safety of drugs used in trial |
Assessed at 2, 4 and 6th week |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 comparative
study of efficacy and safety of Superbioavailable Itraconazole(SBITZ130) and
conventional Itraconazole(CITZ 200) in patients with dermatophytosis in a
tertiary care hospital. It is an open
label, prospective, double arm, parallel and single centered interventional
study. The primary endpoint
of the study will be to compare the percentage of patients achieving a complete
cure (clinical cure plus mycological cure) at the end of the treatment period
from baseline in both the groups. It will be assessed on the basis of the Lesion Severity Score (LSS) and the Area Severity Score (ASS). The Secondary outcome end point will be to
assess the recurrence of dermatophytosis at the end of 10th week and safety of
drugs used in both arms at 2nd , 4th and 6th week. |