| CTRI Number |
CTRI/2025/10/095899 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on cosmetic product use among adults |
|
Scientific Title of Study
|
Evaluation of cosmetic product use among the adult population: A prospective
observational 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 |
Prathiksha Dogu Poojary |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9380240092 |
| Fax |
|
| Email |
prathiksha.mcopsmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammed Salim KT |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9656798071 |
| Fax |
|
| Email |
salim.kt@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prathiksha Dogu Poojary |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9380240092 |
| Fax |
|
| Email |
prathiksha.mcopsmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Pharmaceutical Sciences, Madhav Nagar, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Pharmaceutical Sciences |
| Address |
Manipal College of Pharmaceutical Sciences, Madhav Nagar, Manipal, Udupi, Karnataka, 576104 |
| 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 |
| Prathiksha Dogu Poojary |
Kasturba Hospital |
Department of Pharmacy Practice, 4th Floor, Manipal College of Dental Sciences, Manipal, 576104
Udupi
KARNATAKA |
9380240092
prathiksha.mcopsmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Males and females who use cosmetic products |
|
| ExclusionCriteria |
| Details |
Individuals with pre-existing chronic dermatological conditions and who are not willing to
participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Usage patterns of cosmetic products among adults in the general population |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The occurrence and classification of adverse cosmetic reactions reported by participants |
6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
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
|
The study will be conducted among the general population at Radha Medicals, Manipal, with the required permission granted to conduct the research there. The participants will be informed about the study and about their voluntary participation. Eligible participants will be enrolled after administering the informed consent forms. Baseline information such as demographic details of the subjects, cosmetics used, adverse cosmetic reactions, its management and the awareness of cosmetovigilance will be collected in a suitably designed data collection format. Participants will then be followed up telephonically once a week for the next three weeks to monitor any adverse reactions to cosmetic products in use. The names and contact numbers of the participants will be maintained solely by the investigator in a logbook for the purpose of follow-up communication and will be destroyed after the completion of the study. Causality assessment will be applied using Colipa Causality Assessment Method for each of the adverse cosmetic event will be performed. |