| CTRI Number |
CTRI/2018/07/014697 [Registered on: 02/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety testing of cosmetic product by patch test on subjects with sensitive skin |
|
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 |
| 1718CICL708 Protocol Version 01 dated 06 Jun 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
09582645711 |
| Fax |
|
| Email |
a.jain@cidp-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annie Jain |
| Designation |
Principal Investigator |
| Affiliation |
CIDP Biotech India Pvt Ltd |
| Address |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
DELHI
110005
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 |
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
32B First Floor, Rajinder Nagar, Pusa Road, New Delhi
Central
DELHI
110005
India |
| Phone |
01140793385 |
| Fax |
|
| Email |
r.gupta@cidp-cro.com |
|
|
Source of Monetary or Material Support
|
| The trail has been funded by ITC Life Sciences Technology Centre |
|
|
Primary Sponsor
|
| Name |
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 |
CIDP Biotech India Pvt. Ltd. |
32B First Floor, Rajinder Nagar, Pusa
Road New Delhi
Central
DELHI |
011409793385
a.jain@cidp-cro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-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 included |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product 1- Handwash, Product 2- Handwash, Product 3- Handwash,Product 4- Handwash, Product 5- Handwash, Product 6- Handwash, Product 7- Handwash, Product 8- Talc, Product 9- Deodorant, Product 10- Deodorant, Product 11- Deodorant,
Product 12- Deodorant,
Product 13- Deodorant,
Product 14- Deodorant,
Product 15- Deodorant,
Product 16- Deodorant,
Product 17- Deodorant,
Product 18- Floor Sanitizer,
Product 19- Floor Sanitizer,
Product 20- Floor Sanitizer |
All the investigational products will be applied once on Day 0 for a duration of 24 hours topically under occlusion |
| Comparator Agent |
SODIUM LAURYL SULPHATE AR GRADE |
3% SLS will be applied to the subjects |
|
|
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 |
Safety assessment of investigational products for
irritation potential using Draize scale done on 0
hour after patch removal, 24 hours after patch removal and 7 days post patch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
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)
|
04/07/2018 |
| Date of Study Completion (India) |
17/07/2018 |
| 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
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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 |