| CTRI Number |
CTRI/2021/04/032587 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patch Testing for Safety] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety Testing of cosmetic product by Patch test |
|
Scientific Title of Study
|
Evaluation of Dermatological safety of Test products by primary irritation patch test on healthy human volunteers of varied skin types |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL-CT-001-PIPT-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvi Panchal MD |
| Designation |
Principal Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited
136 Sector-5, IMT, Manesar Haryana
Gurgaon
HARYANA
122050
India |
| Phone |
01244006445 |
| Fax |
|
| Email |
drurvi77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urvi Panchal MD |
| Designation |
Principal Investigator |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited
136 Sector-5, IMT, Manesar Haryana
Gurgaon
HARYANA
122050
India |
| Phone |
01244006445 |
| Fax |
|
| Email |
drurvi77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Gupta |
| Designation |
Study Manager |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited
136 Sector-5, IMT, Manesar Haryana
Gurgaon
HARYANA
122050
India |
| Phone |
01244006445 |
| Fax |
|
| Email |
rajat.gupta@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Freedom Fragrances |
| Address |
234 C, Attarwala Compound, M.A. Road Mumbai-400008 |
| 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 Urvi Panchal |
Auriga Research Private Limited |
136 Sector-5, IMT Manesar Gurugram, Haryana
Gurgaon
HARYANA |
9540930950
drurvi77@gmail.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 |
Adult healthy subjects (Male and Female) in the age group of 18 years to 45 years (both inclusive) will be selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Baby Nappy Rash Cream
2. Baby talcum Powder
3. Baby Oil
4. Baby Lotion
5. Baby Shampoo
6. Baby Shower gel |
1. For product 1, 3, 4 the product is leave on product, so is placed directly in the aluminum chambers of the patch and applied on the back of the volunteers
2. For Product 2 (baby talcum Powder) 1:1 slurry of test sample in distilled water will be dispensed onto the centre of an appropriately sized filter paper placed in the designated Finn chamber prefixed to a micro pore tape.
3. For products 5 & 6 the products are diluted 8% and solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers The products is applied for 24 hours under occlusion |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) 1% Solution |
1% SLS Solution is applied for 24 hours under occlusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects in the age group of 18-45 years (both age inclusive)
2. Subjects with Fitzpatrick skin type III to V
3. Subjects willing to give a voluntary written informed consent
4. Subjects willing to maintain the test patches in designated positions for 24 Hours
5. Subjects having not participated in a similar investigation in the past two weeks
6. Subjects willing to come for regular follow up visits
7. Subjects ready to follow instructions during the study period
8. Subjects without any open wounds, cuts, abrasions, irritation symptoms |
|
| ExclusionCriteria |
| Details |
1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application
2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results
3. Subject is Pregnant or Lactating
4. Athletes and subjects with a history of excessive sweating
5. Subjects on an oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results
6. Subjects participating in any other cosmetic or therapeutic trial
7. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease, or history of alcoholism, HIV, or any other serious medical illness |
|
|
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 at 0 hour, 24 hours and 7 days post patch removal. |
Safety assessment of investigational products for irritation potential using draize scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2021 |
| Date of Study Completion (India) |
15/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. 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 of 1:1) adult subjects in the age group of 18 years to 45 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) |