| CTRI Number |
CTRI/2020/06/025629 [Registered on: 05/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effects of two drugs metronidazole and tacrolimus steroid induced rosacea. |
|
Scientific Title of Study
|
Comparative study of efficacy and safety profile of topical Metronidazole and topical Tacrolimus in Steroid induced Rosacea in tertiary care teaching hospital Haldwani |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavana srivastava |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Bhavana Srivastava, Type IV/ G3, Government Medical College Campus, Rampur
Road, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895782824 |
| Fax |
|
| Email |
drsbhavana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana srivastava |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Bhavana Srivastava, Type IV/ G3, Government Medical College Campus, Rampur
Road, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895782824 |
| Fax |
|
| Email |
drsbhavana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana srivastava |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Dr Bhavana Srivastava, Type IV/ G3, Government Medical College Campus, Rampur
Road, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895782824 |
| Fax |
|
| Email |
drsbhavana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical collage Haldwani |
| Address |
Government medical collage, Haldwani, Nainital, UTTARAKHAND |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SELF |
Room no. F-13, new male PG hostel, Government medical collage, Haldwani, Nainital, UTTARAKHAND |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VIKRAM SINGH DHAPOLA |
Government Medical collage and associated Dr. Susheela Tiwari Government hospital, Haldwani |
Department of Pharmacology and Department of Dermatology,Veronology and Leprology
Nainital
UTTARANCHAL |
9557288405
drdhapola90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE HALDWANI NAINITAL UTTARAKHAND |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tacrolimus cream 0.03% |
12 hourly a day for topical application for 8 weeks |
| Intervention |
Topical metronidazole gel 0.075% |
12 hourly a day for topical application for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with steroid induced rosacea.
2.Age 18 years and above.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and Lactating Women.
2.Drug allergy .
3. Children less than 18 years
4.Patients with systemic disease.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the efficacy of 0.75% metronidazole gel and 0.03% tacrolimus cream in steroid induced rosacea. |
The patients will be followed up on 1st, 3rd, 5th and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Study the adverse effects of 0.75% metronidazole gel and 0.03% tacrolimus cream.
2. To study the cost of the therapy.
|
The patients will be followed up on 1st, 3rd, 5th and 8th week.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/06/2020 |
| 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="6"
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
|
Rosacea is a chronic, inflammatory skin disease of obscure etiology,characterizd by facial erythema and telangiectasia with varying degree of inflammatory skin lesion like papule and pustule. The disease is though to be of immune origin. main precipitating event proposed for the disease include UV light, microbes and hormonal imbalance. As there is scarcity of data regarding use and effectiveness of topical metronidazole and tacrolimus cream in steroid induced rosacea in patients of kumaon region, so this study will be done in department of Dermatology and Department of Pharmacology of GMC Haldwani.
|