| CTRI Number |
CTRI/2019/06/019600 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
06/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the effectiveness of oral itraconazole with low dose and high dose isotretinoin in the treatment of tinea |
|
Scientific Title of Study
|
Comparative efficacy of oral Itraconazole alone and in combination with low dose and high dose Isotretinoin in the treatment of dermatophytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shradha |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital ; sector 32 , chandigarh |
| Address |
Government Medical College and Hospital , Department of Dermatology , Sector 32 , Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7837398348 |
| Fax |
|
| Email |
jshradha2492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Bhalla |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital , sector 32, chandigarh |
| Address |
Government Medical College and Hospital , Department of Dermatology , sector 32 , Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shradha |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital , sector 32, chandigarh |
| Address |
Government Medical College and Hospital , Department of Dermatology , Sector 32 , Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7837398348 |
| Fax |
|
| Email |
jshradha2492@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital , sector 32 , chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of dermatology |
| Address |
Government medical college and hospital , sector 32 , chandigarh |
| Type of Sponsor |
Government 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 Shradha |
Government Medical College and Hospital |
Room number 4319 , Dermatology , Venereology and Leprosy OPD , B block , 4th floor , Government medical college and hospital , sector 32 , Chandigarh
Chandigarh
CHANDIGARH |
7837398348
jshradha2492@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral itraconazole |
Patients will be given oral capsule itraconazole 100 mg twice daily for a period of four weeks |
| Comparator Agent |
Oral itraconazole with oral isotretinoin |
Patient will be given oral itraconazole 100 mg twice daily along with oral low dose isotretinoin i.e 20 mg once daily for four weeks |
| Comparator Agent |
Oral itraconazole with oral isotretinoin |
Patient will be given oral itraconazole 100 mg twice daily for four weeks along with oral high dose isotretinoin i.e 20 mg twice daily for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. KOH positivity on direct microscopy showing septate hyphae of dermAtophytosis .
2. Patients with extensive disease requiring systemic therapy .
3. Patients above 18 years of age . |
|
| ExclusionCriteria |
| Details |
1. Patients with co-existing dermatophytosis involving hairs, nail, palms and soles.
2. Patients with hepatic , renal derangement , abnormal lipidvprofile or any significant systemic illness.
3. Patients on immunosuppressive agents.
4. Pregnant and lactating women .
5. Women of child bearing age not using contraception indicated for systemic retinoids therapy . |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the therapeutic efficacy of concomitant use of low and high dose isotretinoin along with itraconazole in dermatophytosis |
0,2,4,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for adverse effects of combination of Itraconazole and Isotretinoin |
0,2,4,8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/06/2019 |
| 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="1"
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)?
|
|
Brief Summary
|
Dermatophytosis is caused by mainly Trichophyton , Epidermophyton and MIcrosporum affecting more than 20- 25% of world’s population. Recently there has been an alarming rise in the number of dermatophytosis patients as well as the recalcitrant cases . The recent change in the dermatophyte infection has resulted in a change in its response to treatment as well. The conventional systemic agents like griseofulvin , ketoconazole , fluconazole and even the newer synthetic agents like itraconazole , terbinafine are no longer effective as they were initially . The present study is being designed to assess the role of isotretinoin in low and high dose as an adjuvant along with oral itraconazole in treatment of dermatophytosis. It aims to find whether patients treated with this combination have better efficacy and less treatment failures . |