| CTRI Number |
CTRI/2024/05/066802 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to analyze the drug prescribing pattern with their side effect profile and effect of such treatment on Quality of Life among patients of acne vulgaris disease. |
|
Scientific Title of Study
|
A prospective observational study for evaluating drug prescribing pattern and effect of treatment on Quality of Life in acne vulgaris patients attending dermatology outpatient in tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No. 3014, Level 4, Department of Pharmacology, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9458651765 |
| Fax |
|
| Email |
kumarpramod6764@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Chikara |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No. 3008, Level 4, Department of Pharmacology at AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9587262037 |
| Fax |
|
| Email |
gaurav.phar@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Chikara |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No. 3008, Level 4, Department of Pharmacology at AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9587262037 |
| Fax |
|
| Email |
gaurav.phar@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Virbhadra Road, Rishikesh
Uttarakhand- 249203, India
|
|
|
Primary Sponsor
|
| Name |
Pramod Kumar |
| Address |
Room No. 3014, Level 4, Department of Pharmacology, AIIMS Rishikesh |
| 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 |
| Pramod Kumar |
AIIMS Rishikesh |
Room No. 3014, Department of Pharmacology, Level 4
Dehradun
UTTARANCHAL |
9458651765
kumarpramod6764@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Rishikesh 249203 |
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 |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly enrolled Acne vulgaris patients seeking medical intervention for first time at AIIMS Rishikesh
Age more than and equal to 15 years from either gender (male / female).
Patient willing to undergo treatment and follow ups.
Patient willing to give written informed consent to participate in study |
|
| ExclusionCriteria |
| Details |
Withdrawal of consent at any point after enrolment but before completion of follow-up.
Pregnant and Lactating women.
Patients diagnosed with systemic comorbidity/comorbidities requiring chronic treatment.
Any dermatologic disease other than acne vulgaris.
Patients with secondary causes of Acne like Drug induced Acne/acneiform eruptions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-To analyse drug prescribing pattern in acne vulgaris patients in relation to severity of acne and prevailing treatment guidelines.
2-To assess effect of treatment on quality of life in acne vulgaris patients, using Dermatology Life Quality Index (DLQI) and acne- specific Cardiff Acne Disability Index (CADI) at multiple time points of therapy. |
1-At baseline visit
2-at 0(baseline), 3, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess effect of treatment on self-esteem in acne vulgaris patients, using Rosenberg Self-esteem Scale (RSES) at multiple time points of therapy. |
at 0(baseline), 3, and 6 months |
| To study the adverse event profile of treated acne vulgaris patients with active reporting of adverse events in patients treated with Retinoids. |
During OPD visits (3, and 6 months) and through telephonic calls. |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
14/05/2024 |
| 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="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
|
Acne is one of the most prevalent skin conditions observed in adolescent which remain continued even into adulthood. This chronic condition is associated with significant negative psychosocial impact, but it is frequently underestimated. Adult acne appears to have a greater impact on quality of life than acne in adolescents or younger adults. Limited Indian studies are there analysing prescription pattern, but no Indian study was found assessing change of Quality of life (QoL) with treatment while limited data is published from outside India. This study was designed to analyse drugs prescribing pattern, effect of drug therapy on Quality of Life (QoL) and adverse event profile in Acne vulgaris patients. This information is expected to be helpful in tailoring treatment approaches, providing appropriate counselling, and improving patient outcomes.
|