| CTRI Number |
CTRI/2022/05/042655 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect and safety of super bioavailable Itraconazole 50 mg vs 65 mg in a disease condition called Glabrous tinea |
|
Scientific Title of Study
|
An open label, prospective, double arm clinical study to compare the effectiveness and safety of super bioavailable Itraconazole capsules 50 mg BD vs 65 mg BD in the management of Glabrous tinea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS/2022/01 Version 1.0 dated 27-Jan-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deval Mistry |
| Designation |
Consultant |
| Affiliation |
Dr R R Gupta and Dr Deval Mistry s Skin Clinic |
| Address |
108, Abhinav Arcade,
Pritamnagar, Paldi,
near Kothawala Flats,
Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380007
India |
| Phone |
919998289508 |
| Fax |
|
| Email |
deval.neogeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deval Mistry |
| Designation |
Consultant |
| Affiliation |
Dr R R Gupta and Dr Deval Mistry s Skin Clinic |
| Address |
108, Abhinav Arcade,
Pritamnagar, Paldi,
near Kothawala Flats,
Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380007
India |
| Phone |
919998289508 |
| Fax |
|
| Email |
deval.neogeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deval Mistry |
| Designation |
Consultant |
| Affiliation |
Dr R R Gupta and Dr Deval Mistry s Skin Clinic |
| Address |
108, Abhinav Arcade,
Pritamnagar, Paldi,
near Kothawala Flats,
Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380007
India |
| Phone |
919998289508 |
| Fax |
|
| Email |
deval.neogeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
Glenmark House BD Sawant Marg Andheri East Mumbai 400099 |
|
|
Primary Sponsor
|
| Name |
Dr Deval Mistry |
| Address |
108, Abhinav Arcade,
Pritamnagar, Paldi,
near Kothawala Flats,
Ahmedabad, Gujarat 380007 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bela Shah |
B J Medical College and Civil Hospital |
Department of Dermatology Venereology and Leprology, Room No. 202, Asarwa Ahmedabad- 380016
Ahmadabad
GUJARAT |
9898059289
belashah769@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Om Institutional Ethics Committee |
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 |
| Intervention |
Super bioavailable Itraconazole |
Capsule
65 mg twice daily to be administered with food for 6 weeks |
| Comparator Agent |
Super bioavailable Itraconazole |
Capsule 50 mg twice daily to be administered with food for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients eligible for enrolment in the study must meet all of the following criteria:
1. Both male and female patients aged ≥ 18 years and ≤ 60 years.
2. Patients with diagnosis of Glabrous tinea on KOH mount requiring systemic antifungal therapy.
3. Females of child bearing potential, who is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives).
4. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age.
5. Patients who the study staff deems reliable and mentally competent to carry out the study. |
|
| ExclusionCriteria |
| Details |
Patients meeting any of the following criteria must not be enrolled in the study:
1. Pregnant or nursing females.
2. Patients with known hypersensitivity to the study drugs.
3. Patients with liver dysfunction.
4. Patients with a history of seizures
5. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject’s safety or interfere with the study assessments.
6. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subject’s ability to safely complete the study.
7. History of drug or alcohol dependency or abuse within approximately the last 2 years.
8. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
9. Patients with malignancy.
10. Any patient whom the investigator judged to be inappropriate for this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is to evaluate the proportion of patients achieving complete cure at Week 6 following doses of super bioavailable itraconazole 65 mg BD compared to 50 mg BD (Complete cure is defined as patients achieving both clinical and mycological cure at the end of therapy). |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal and derangement in Liver function test (LFTs) will be summarized by treatment groups
o Percentage of patients achieving clinical cure. (Clinical cure is defined as absence of clinical signs and symptoms at the end of therapy)
o Percentage of patients achieving mycological cure. (Mycological cure is defined as negative microscopy under potassium hydroxide (KOH) examination at the end of therapy).
o Improvement in quality of life by Dermatology Life Quotient Index (DLQI) questionnaire |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/05/2022 |
| Date of Study Completion (India) |
30/09/2022 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Open label, prospective, randomized, comparative, double arm study.
Eligible patients will be screened and upon confirmation on KOH mount will be
enrolled in the study. Efficacy and safety assessments will be done at week 3
and week 6. Follow up of all completely cured patients will be done at week 10
for recurrence if any as an exploratory endpoint. Quality of Life will be
assessed pre and post treatment. |