| CTRI Number |
CTRI/2017/05/008582 [Registered on: 17/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| 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 subjects with sensitive skin |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1617CICL920 Protocol Version 01 dated 28 Apr 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
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
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Haobam Rakesh Singh |
| Designation |
Study Manager |
| Affiliation |
CIDP Biotech India Pvt. Ltd |
| Address |
CIDP Biotech India Pvt. Ltd
32B First Floor, Rajinder Nager, Pusa Road
New Delhi
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
r.singh@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC Limited ITC Life Sciences Technology Centre |
| Address |
No3 1st Main Road Peenya Industrial Area
1 Phase Bengaluru - 560058
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
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.Rinse-off (Hand wash)
2.Rinse-off (Hand wash)
3.Rinse-off (Hand wash)
4. Rinse-off (Hand wash)
5. Rinse-off (Face wash)
6. Rinse-off (Face wash)
7.Rinse-off (Face wash)
8.Rinse-off (Chalk)
9.Skin Leave- On
10.Skin Leave –On |
 Rinse-Off Products (7256, 7257, 7258, 7252, L6735A, L6736A(SL), L6747):
8% w/W sample solution: 8gms of test samples is dissolved in 80gms of distilled water and made upto 100 gm solution using distilled water.
 Rinse-Off Products (TSP 108-115(Chalk):
The product is to be ground to fine particles and 8 gms of the ground product is diluted with distilled water to arrive at a concentration of 8% w/w in distilled water. The solution is allowed to settle under ambient conditions for some time (5-10mins) and only the clear supernatant is to be used for patch application
 Leave-On products (6180A, 6180B):
These are applied as such without any dilution
|
| 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 in good general health
3. Subjects with Fitzpatrick skin type III to V
4.Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire
5.Subject identified to have sensitive skin basis dermatologist’s assessment of skin with fine texture and closeness of blood vessels to the surface
6.Subjects willing to give a voluntary written informed consent
7. Subjects willing to maintain the test patches in designated positions for 24 hours
8. Subjects having not participated in a similar investigation in the past eight weeks
9. Subjects willing to come for regular follow up visits
10. Subjects ready to follow instructions during the study period
11. Subjects without any open wounds, cuts, abrasions, irritation symptoms
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a present condition of allergic response to any cosmetic product
2. Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study
3. Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy)
4. Subjects with cutaneous disease that could interfere with the study results
5. Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness
6. Subjects participating in any other cosmetic or therapeutic trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety assessment of investigational products for irritation potential using Draize scale |
Draize scoring to be done at 0 hr, 24 hrs and day 7 of patch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2017 |
| Date of Study Completion (India) |
19/05/2017 |
| 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 with sensitive skin.Primary irritation patch test is used widely for the evaluation of safety of cosmetics in humans. Sample Size :Thirty Five (male and female, in a nearly 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) &IS 13424:2001
|