| CTRI Number |
CTRI/2025/10/096020 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [[cosmetic product for safety evalution]] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety evaluation of cosmetic products |
|
Scientific Title of Study
|
Evaluation of safety of Test products by primary irritation patch test on healthy human
participants of varied skin types |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL-CT-032-25 Version 01 Dated 30-Sep-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karishma Kapoor |
| Designation |
Principle Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India |
| Phone |
09871953143 |
| Fax |
|
| Email |
karishma.kapoor@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Quest Retails private Limited DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLF phase 2 |
|
|
Primary Sponsor
|
| Name |
Quest Retails private Limited |
| Address |
DLF Infinity tower A 7th Floor DLF Cyber city M G Road Gurgaon 122002 DLF phase 2 |
| 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 Karishma Kapoor |
Auriga Research Private Limited |
3/17 2nd Floor Cosmetic Division Kirti Nagar Industrial State New Delhi
New Delhi
DELHI
110015
India
New Delhi
DELHI |
09871953143
karishma.kapoor@aurigaresearch.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boddess Beauty Dayshield SPF 50 B No FND36081 |
Neat 0 04mg single dose topical application 24 hr |
| Intervention |
Boddess FilterFx Primer B No FND36413 |
Neat 0 04mg single dose topical application 24 hr |
| Comparator Agent |
Negative Control |
Neat 0 04mg of (0.9% w/w sodium chloride in distilled water) single dose topical application 24 hr |
| Comparator Agent |
Positive control |
Neat 0 04mg of (1% w/w sodium lauryl sulphate in distilled water) single dose topical application 24 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male and female Participants in the age group of 18-65 years both age inclusive Participants with skin photo type III to V Participant is having apparently healthy skin on test area
Participants representing normal oily dry and combination skin type in nearly equal ratio
Participants willing to give a voluntary written informed consent |
|
| ExclusionCriteria |
| Details |
Hypersensitivity allergy antecedent to any cosmetic product raw material or hair dye Participants having any significant pathology Dermatological infection in the test area Participant is Pregnant or Lactating
Participants participated in any other cosmetic or therapeutic trial or in a similar investigation
Participant is having Scars excessive terminal hair or tattoo on the studied area |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety assessment of investigational products for
irritation potential using Draize scale after patch
removal |
0 hours 24 hours and 7 days post patch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
24/10/2025 |
| 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="0"
Months="0"
Days="9" |
|
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 objective of this study is to evaluate the dermatological safety of the investigational products on healthy human participants A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans Sample Size Twenty four (male and female in a nearly equal ratio ) adult participants in the age group of 18 years to 65 years (both inclusive) Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance By this test irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (BIS4011 2018) |