| CTRI Number |
CTRI/2024/12/078264 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy and safety profile of topical ivermectin versus topical metronidazole in patients with side effects like red-raised or pus-filled lesions, redness, itching, burning sensation, etc due to long-term use of topical steroid on face in a tertiary care teaching hospital. |
|
Scientific Title of Study
|
Efficacy and safety profile of topical ivermectin and topical metronidazole in steroid induced rosacea in tertiary care teaching hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr CHIRAG SAINI |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Dermatology & Venereology, Government Medical College, Haldwani, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895560725 |
| Fax |
|
| Email |
chirags536@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHIRAG SAINI |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Dermatology & Venereology, Government Medical College, Haldwani, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895560725 |
| Fax |
|
| Email |
chirags536@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CHIRAG SAINI |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College Haldwani |
| Address |
Department of Dermatology & Venereology, Government Medical College, Haldwani, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895560725 |
| Fax |
|
| Email |
chirags536@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Chirag Saini, Department of Dermatology and Venereology, Government Medical College, Haldwani, Uttarakhand, India, Pin-code 263139 |
|
|
Primary Sponsor
|
| Name |
Dr CHIRAG SAINI |
| Address |
Government Medical College Haldwani, Dr. SUSHEELA TIWARI GOVERNMENT HOSPITAL, RAMPUR ROAD, HALDWANI, NAINITAL, UTTARAKHAND |
| 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 Chirag Saini |
Dr. Susheela Tiwari Government Hospital, Rampur Road, Haldwani |
OPD Room no- 24, Ground floor, Department of Dermatology, Venereology & Leprosy
Nainital
UTTARANCHAL |
7895560725
chirags536@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GOVERNMENT MEDICAL COLLEGE HALDWANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L718||Other rosacea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Ivermectin 1% cream |
to apply once daily at night for 3 months |
| Comparator Agent |
Topical Metronidazole 2% gel |
to apply once daily at night for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex, 18-65 years age, with steroid induced rosacea.
2. Patient is off topical steroids for at-least 2 weeks. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating Women.
2. Drug allergy.
3. Children less than 18 years
4. Patients with Autoimmune Connective Tissue disease.
5. Associated Acne patients |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the efficacy of 2 % metronidazole gel and 1% ivermectin cream in steroid induced rosacea. |
Patients will be followed up on 3th, 6th, 9th and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the safety profile of 2% metronidazole gel and 1% ivermectin cream. |
Patients will be followed up on 3th, 6th, 9th and 12th week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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 Yet Recruiting |
| 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
|
The study will be conducted to see the efficacy of topical ivermectin & topical metronidazole in steroid induced rosacea. Topical steroids being prescribed by many professionals for various skin conditions, easy availability at nearby pharmacies, at very cheap prices, and with no regulation on their sale as an OTC drug, the need to study about the remedies for the side effects caused by topical steroid abuse is an absolute necessity. |