| CTRI Number |
CTRI/2025/10/095974 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing self-medication and doctor-prescribed treatment in patients with acne to find which gives better, safer, and more cost-effective results |
|
Scientific Title of Study
|
Impact Of self-medication on therapeutic and economical outcomes in patients of Acne Vulgaris in comparison with prescription medication in dermatology department of a tertiary care teaching hospital: A comparative interventional Study. |
| 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 Geetanjali Salimath |
| Designation |
Associate Professor |
| Affiliation |
KLE College Of Pharmacy, Belagavi. |
| Address |
Department of Pharmacy Practice Room No. 15, KLE College of Pharmacy, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetanjalisalimath@klepharm.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Salimath |
| Designation |
Assistant Professor |
| Affiliation |
KLE College Of Pharmacy, Belagavi |
| Address |
Department of Pharmacy Practice Room No. 15, KLE College of Pharmacy, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetanjalisalimath@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sharwin Dsouza |
| Designation |
Intern |
| Affiliation |
KLE College Of Pharmacy, Belagavi |
| Address |
Department of Pharmacy Practice Room No. 15, KLE College of Pharmacy, Nehru Nagar Belagavi.
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9620381625 |
| Fax |
|
| Email |
sharwindsouza2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital, Nehru Nagar Belagavi- 590010 |
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy Belagavi |
| Address |
KLE College of Pharmacy, Nehru Nagar Belagavi- 590010. |
| Type of Sponsor |
Research institution |
|
|
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 Geetanjali Salimath |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre. |
Room No. 23, Dermatology department OPD.
Belgaum
KARNATAKA |
9902687176
geetanjalisalimath@klepharm.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
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 |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pharmacist intervention. |
Adverse drug reaction (ADR) monitoring will be conducted for both self-medicated and prescription-based treatments to identify and prevent potential side effects.
Patient Counselling will be given to patients on proper medication use and necessary lifestyle modifications to promote faster recovery and improved treatment outcomes. As part of pharmaceutical care, the pharmacist will actively monitor drug therapy, identify and resolve drug-related problems, and ensure the safe and effective use of medications. This includes assessing potential drug interactions, providing education on correct medication use, and reinforcing adherence and lifestyle modifications to enhance clinical and economic outcomes.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients confirmed with diagnosis of Acne Vulgaris.
Both female and male patients of OPD of age 15-35 years.
Willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patients with severe comorbidities.
Patients with Immunodeficiency disorder.
Patients who have been previously initiated on prescription medication by other dermatologists.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Clinical effectiveness in prescription versus self-medication patients.
2.Incidence and severity of adverse effects. |
Baseline & after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Direct & indirect costs associated with each therapy.
2.Improvement in quality of life of the patient
|
Baseline & after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
01/11/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to evaluate and compare the
therapeutic and economic outcomes of self-medication versus prescription-based
treatment in patients with acne vulgaris attending a dermatology department in
a tertiary care teaching hospital. Acne vulgaris is a common chronic
inflammatory skin condition that often leads individuals to self-medicate,
increasing the risk of side effects, drug interactions, and higher treatment
costs. This comparative interventional study will assess the clinical efficacy,
safety, cost effectiveness, and quality of life among patients using self-medication
and those following dermatologist prescribed therapy. The study also explores
the role of pharmacist intervention in improving patient outcomes and promoting
rational drug use. Data will be collected using standardized assessment tools,
and outcomes will be analysed statistically to determine differences between
the two groups. |