| CTRI Number |
CTRI/2017/03/007984 [Registered on: 01/03/2017] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| 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 products by patch test |
|
Scientific Title of Study
|
Evaluation of Dermatological safety of Investigational products by primary irritation patch test on healthy human volunteers of varied skin types |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1617CICL653, Version 01 dated 13 Feb 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain MD |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
CIDP Biotech India Pvt. Ltd
32B First Floor, Rajinder Nager, Pusa Road
New Delhi
New Delhi
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain MD |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
CIDP Biotech India Pvt. Ltd
32B First Floor, Rajinder Nager, Pusa Road
New Delhi
New Delhi
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geet Agrawal |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
CIDP Biotech India Pvt. Ltd
32B First Floor, Rajinder Nager, Pusa Road
New Delhi
New Delhi
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
g.agrawal@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences Technology Centre |
| Address |
Peenya Industrial area,
I Phase, Peenya
Bangalore- 560058
Karnataka, India
|
| Type of Sponsor |
Other [Research and Development] |
|
|
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 Annie Jain MD |
CIDP Biotech India Pvt. Ltd. |
32B First Floor, Rajinder Nager, Pusa Road,
New Delhi
New Delhi
DELHI |
01140793385
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - ADITYA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult subjects in the age group of 18 years to 55 years (both inclusive) will be selected |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Soap 2. Soap 3. Soap 4. Soap 5. Perfume spray 6. Talc 7.Talc 8. Face Wash 9.Wipe 10. Hair Leave on |
1. For products 1 to 4 the products are diluted 8% and solution are dispensed in the aluminum chambers of the patch and applied on the back of the volunteers. 2. For Product 5, the product is aerosol product. So it is applied by semi-occlusive method. The product is dispensed directly on the skin on the back of volunteer and it is occluded by the patch after it gets evaporated. 3. For product 6 & 7 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. 4. For product 8 the product is diluted 8% and solution are dispensed in the aluminium chambers of the patch and applied on the back of the volunteers. 5. For product 9 appropriate size of the test substrate will be cut (as per the size of finn chamber) and placed on the centre of a clean Finn chamber prefixed to a micro pore tape. 6. For product 10 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 |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) 3% Solution |
3% Solution |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female subjects in the age group of 18-55 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 history of excessive sweating
5. Subjects on 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. |
Draize scoring to be done at 0 hr, 24 hr and day 7 of patch removal. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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)
|
01/03/2017 |
| Date of Study Completion (India) |
10/03/2017 |
| 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
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objective :The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects.Primary irritation patch test is used widely for the evaluation of safety of cosmetics in humans. Sample Size :Twenty four (male and female, in a ratio of 1:1) adult subjects in the age group of 18 years to 55 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 (IS4011:1997) |