| CTRI Number |
CTRI/2025/03/083191 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study focusing on observing and describing different medication recommended for treating acne in patients who visit skin clinic at SMS Hospital, Jaipur |
|
Scientific Title of Study
|
A descriptive observational study to assess the drug prescription pattern in patients of acne vulgaris attending outpatient Department of Dermatology & Venereology at SMS Hospital, Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yesha Chaudhari |
| Designation |
Postgraduate Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan,India-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9099684965 |
| Fax |
|
| Email |
c.tabu02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Uma Advani |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan,India-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413510355 |
| Fax |
|
| Email |
drupadvani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uma Advani |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Pharmacology, SMS Medical College, Jaipur, Rajasthan,India-302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413510355 |
| Fax |
|
| Email |
drupadvani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and Hospital, Jaipur, Rajasthan, India (Pincode:-302004) |
|
|
Primary Sponsor
|
| Name |
Yesha Chaudhari |
| Address |
Department of Pharmacology, Sawai man Singh Medical College, Jaipur, Rajasthan, India (Pincode :-302004) |
| 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 Yesha Chaudhari |
Sawai Man Singh Hospital |
Outpatient Department, Department of Dermatology & Venereology, Sawai Man Singh Hospital, Charak bhawan, JLN Marg, Ashok Nagar, Jaipur, Rajasthan, India-302001
Jaipur
RAJASTHAN |
9099684965
c.tabu02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospitals , Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both gender above 18yrs of age
2. Patients diagnosed with acne vulgaris of any grade/degree visiting the outpatient Department of Dermatology & Venereology |
|
| ExclusionCriteria |
| Details |
1. Patient non-cooperative or not willing to give written informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Average number of drugs per prescription
Percentage of drugs prescribed with generic name
Percentage of encounter(prescription) with antimicrobials prescribed
Percentage of encounters(prescription) with injections prescribed
Percentage of drugs prescribed from Essential Drugs List (EDL),Rajasthan.(According to 22th list,2022)
Proportion of prescriptions with potential drug-drug interactions by UpToDate Drug Interaction Checker |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of various grading of acne via GAGS Score for acne severity |
At baseline only |
| Distribution of prescribed drugs according to Anatomic Therapeutic Chemical Classification. |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
11/04/2025 |
| 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="3"
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 purpose of these study is to comprehend and describe the current prescribing pattern as per WHO Indicators, drug-drug interaction in patients diagnosed with acne vulgaris. As well as, it also provide insight on grading clinical profile of acne via GAGS Score & classifying the drugs as per (ATC)Anatomical Therapeutic Classification ,attending the out-patient department of Dermatology & Venereology , SMS Hospital, Jaipur, Rajasthan, India |