| CTRI Number |
CTRI/2018/06/014456 [Registered on: 07/06/2018] Trial Registered Prospectively |
| Last Modified On: |
29/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [1. Skin Leave-on 2. Rinse-off (Face Wash, Shower Gel and Soap) 3. Perfume] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety testing of 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 |
| 1718CICL639, Version 01 dated 16 May 2018 |
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
Central
DELHI
110058
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
110058
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Gupta |
| 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
Central
DELHI
110058
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
r.gupta@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 [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
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 Delh
Central
DELHI |
01140793385
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committe-ACEAS |
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. Skin Leave-On 2.Skin Leave-On 3. Skin Leave-On 4.Rinse-off 5.Skin Leave-On 6. Skin Leave-On 7. Skin Leave-On 8. Skin Leave-On 9. Skin Leave-On 10. Skin Leave-On 11. Skin Leave-On 12. Skin Leave-On 13. Perfume 14.Perfume 15. Perfume 16. Perfume 17. Perfume 18. Perfume 19. Perfume 20. Perfume |
For Product 1 to 3 and product 13 to 20 leave on
product, so is placed directly in the aluminum chambers of the patch and applied on the back of the volunteers and for product 4 to product 11 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 product is to be applied 0.04ml between the waist and scapula and there is only one application for each volunteer and kept for 24 hours |
| Comparator Agent |
Sodium Lauryl Sulphate (SLS)
3% Solution |
3% Solution. The amount of solution is to be applied is 0.04ml on the back of the volunteer for 24 hours |
|
|
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. |
Safety assessment of investigational products for
irritation potential using Draize scale at 0 hour, 24 hours and Day 7 post patch removal. |
|
|
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)
|
18/06/2018 |
| Date of Study Completion (India) |
26/06/2018 |
| 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)?
|
|
Brief Summary
|
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) |