| CTRI Number |
CTRI/2019/07/019964 [Registered on: 01/07/2019] Trial Registered Prospectively |
| Last Modified On: |
05/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of oral Terbinafine and Itraconazole in stubborn Tinea infections |
|
Scientific Title of Study
|
A Prospective , Randomized , Open Label Study To Evaluate The Efficacy And Safety Of Systemic Terbinafine And Topical Amorolfine Compared to Systemic Itraconazole And Topical Amorolfine In Adult Patients Of Recalcitrant Tinea Cruris |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasudha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Amritsar , Punjab |
| Address |
Department of Pharmacology , Government Medical College , Amritsar ,Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9910715215 |
| Fax |
|
| Email |
sharmavasudha45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navyug Raj Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College , Amritsar |
| Address |
Department of Pharmacology , Government Medical College , Amritsar ,Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9878634358 |
| Fax |
|
| Email |
navyug69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Government medical College, Amritsar |
| Address |
Department of Pharmacology , Government Medical College , Amritsar ,Punjab
Amritsar
PUNJAB
143001
India |
| Phone |
9910715215 |
| Fax |
|
| Email |
sharmavasudha45@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vasudha Sharma |
| Address |
Government Medical College, Circular road, Amritsar |
| 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 Vasudha Sharma |
Government Medical College,Amritsar |
Department of Dermatology and Venereology , Guru Nanak Dev Hospital , Amritsar, Punjab
Amritsar
PUNJAB |
9910715215
sharmavasudha45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Amritsar, Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B356||Tinea cruris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Itraconazole and Amorolfine |
Itraconazole 100 mg BD orally daily and local application of 0.25% Amorolfine BD daily for 8 weeks |
| Intervention |
Terbinafine and Amorolfine |
Terbinafine 250 mg OD orally daily and local application of 0.25% Amorolfine BD daily to one group for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with recalcitrant Tinea Cruris
2. Patients willing to give informed consent and comply with the treatment and follow up |
|
| ExclusionCriteria |
| Details |
1. <18 years and > 65 years age
2. Pregnant or Lactating women
3. Secondary bacterial infections
4. Deep mycosis
5. Immunocompromised patients- Severe uncontrolled Diabetes, HIV/AIDS, chronic glucocorticoid therapy
6. Patients with abnormal liver function and kidney function test
7. Present or past history of malignancy
8. Patients with known history of allergy to Itraconazole or Terbinafine or related drugs
9. patients with history of ischemic heart disease
10. Patients not giving informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare safety and efficacy of Itraconazole and Terbinafine in achieving complete cure in recalcitrant tinea cruris infections by 4 point rating scale |
2,4,6,8,10,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare adverse effect profile of Itraconazole and Terbinafine |
2,4,6,8,10,12 weeks |
| To assess the non-responders, if any |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/07/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dermatophytosis is infection of skin or its derivatives,caused by fungi,known as dermatophytes,leading to erythema,papules,plaques,vesicles, fissures and scaling formation. Dermatophytes, most commonly are caused by Trichophyton species. Most common manifestation in humans is Tinea corporis and Tinea cruris. Recalcitrant Tinea includes relapse, recurrence , re-infection , persistence of infection and chronic tinea cases. this study will be prospective , open label , randomized , parallel, in patients of recalcitrant tinea cruris. Primary objective of the study is to, observe the relative effects of systemic Itraconazole and Terbinafine combined with a common topical agent Amorolfine cream 0.25%, in improvement of clinical profile of patients based on clinical and microbiological assessment. Patients will be divided randomly in 2 groups, A and B comprising of 50 patients each. Group A will receive Itraconazole 100 mg BD daily and topical Amorolfine 0.25% BD daily for local application. Group B will receive Terbinafine 250 mg Od daily and topical Amorolfine 0.25% BD daily for local application. Treatment will be continued for 8 weeks and response will be assessed based on 4 point rating scale. Patients will be evaluated at 2,4,6,8 weeks for the treatment response. Post treatment follow up will be done at 10 and 12 weeks from the start of the treatment.
|