| CTRI Number |
CTRI/2023/12/060667 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on usage of topical corticosteroids in conditions related to the skin |
|
Scientific Title of Study
|
USe of topical corticostEroids in dermatological
conditions: Data from Real-world (USER study) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRL-IND-GGI-049-ATOP/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B Swathi Reddy |
| Designation |
Trial coordinator |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
8374255466 |
| Fax |
|
| Email |
swathibrb@drreddys.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biswajit Aich |
| Designation |
Medical Advisor |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
9864159889 |
| Fax |
|
| Email |
biswajitaich@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Rathod |
| Designation |
Medical Cluster Head Ideation and CR Medical Affairs |
| Affiliation |
Dr Reddys Laboratories Limited |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016
Telangana India
Hyderabad
TELANGANA
500016
India |
| Phone |
9987246597 |
| Fax |
|
| Email |
rahul.rathod@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad 500016, Telangana
India |
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Ltd |
| Address |
Dr Reddys Laboratories Limited Global Generics India 7-1-27 Ameerpet Hyderabad
500016 Telangana India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Shraddha Pitalia |
Healthplix Technologies |
Healthplix Technologies.
2 ndfloor, AWFIS, Vajram Esteva New Survey No. 57/4, Old Survey No. 57/2,
Marathahalli-Sarjapur Outer Ring Road Devarabisanahalli, Varthur Outer Ring Rd, Bengaluru, Karnataka, 560103
Bangalore
KARNATAKA |
8319912668
pitalia.shraddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L208||Other atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.10 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ≥18 years of age diagnosed with psoriasis and prescribed with TCS.
Patients diagnosed with atopic dermatitis/eczema and
prescribed with TCS. |
|
| ExclusionCriteria |
| Details |
Patients with incomplete data with respect to study
requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Usage of TCS in atopic dermatitis/eczema and psoriasis by patient subgroups by age.
Prescription pattern of TCS prescribed to patients diagnosed with psoriasis and atopic dermatitis/eczema. |
this is the study where all endpoints will be assessed baseline. The patients on EMR meeting eligibility criteria from 2017 to 2023 will be evaluated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comorbid conditions & concomitant medications of patients prescribed with TCS for
psoriasis & atopic dermatitis/eczema respectively. |
this is the study where all endpoints will be assessed baseline. The patients on EMR meeting eligibility criteria from 2017 to 2023 will be evaluated |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
01/01/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Real-world, retrospective, cross sectional, EMR-based study to USe of topical corticostEroids (TCS) in dermatological conditions: Data from Real world (USER study).The medical records of the patients meeting the eligibility criteria will be taken into consideration. Patient profiling will be done at the baseline. Treatment pattern will be evaluate at base line. As this is retrospective observation EMR based study, study specific patient recruitment is not applicable. |