| CTRI Number |
CTRI/2022/03/040850 [Registered on: 07/03/2022] Trial Registered Retrospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetic clinical trail] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types |
|
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 |
| 01/074/16(D01-6Q18-ZC-DR16), Version No.:02, 26/12/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddheshwar Mathpati |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
2243349191 |
| Fax |
|
| Email |
siddheshwar@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
2243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd.
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,
Mumbai – 400013, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
2243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial area,
I Phase,
Bangalore- 560058
Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
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 |
| siddeshwar |
MASCOT-SPINCONTROL India Pvt. Ltd. |
Unit 2, Neeru Silk Mills,
Mathuradas Mill compound,
N.M. Joshi Marg - Lower Parel,Mumbai – 400013,
Mumbai
MAHARASHTRA |
022-43349191
siddheshwar@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Perfume Spray (4170 A)
2. Perfume Spray (4171 B)
3. Soap (TSP 113-25B)
4. Soap (TSP 113-24B)
5. Soap (TSP 113-38A)
6. Soap (TSP 113-40A)
7. Soap (TSP 113- 70)
8. Soap (TSP 113- 71)
9. Soap (TSP 113- 44)
10. Soap (TSP 112- 79)
11. Soap (TSP 112 – 102)
12. Soap (TSP 112 – 113)
13. Soap (TSP 112- 121)
14. Soap (TSP 112- 74)
15. Face Wash (L6125)
16. Face Wash (FW5970)
17. Skin Leave-On (AAD- Trial 1)
18. Skin Leave- On (AAN#Trial1)
19. Skin Leave- On (WBS#115/01)
20. Skin Leave-On (HFG#116004)
|
Intervention 1. Perfume Spray (4170 A)
2. Perfume Spray (4171 B)
3. Soap (TSP 113-25B)
4. Soap (TSP 113-24B)
5. Soap (TSP 113-38A)
6. Soap (TSP 113-40A)
7. Soap (TSP 113- 70)
8. Soap (TSP 113- 71)
9. Soap (TSP 113- 44)
10. Soap (TSP 112- 79)
11. Soap (TSP 112 – 102)
12. Soap (TSP 112 – 113)
13. Soap (TSP 112- 121)
14. Soap (TSP 112- 74)
15. Face Wash (L6125)
16. Face Wash (FW5970)
17. Skin Leave-On (AAD- Trial 1)
18. Skin Leave- On (AAN#Trial1)
19. Skin Leave- On (WBS#115/01)
20. Skin Leave-On (HFG#116004) 1. For Product 1&2, the products are 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 at T0 visit.
2. For products 3 to 16, The products are diluted 8% and solution are dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit
3. For products 17 to 20 the products are leave on products so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteers at T0 visit.
|
| Comparator Agent |
Sodium Lauryl Sulphate (SLS) 3% Solution |
Sodium Lauryl Sulphate (SLS) 3% Solution |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
2. Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination)
3. Subjects willing to come for regular follow up and ready to follow instructions during the study period
|
|
| ExclusionCriteria |
| Details |
1. For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give his/her assent by signing the consent form
3. Taking part in another study liable to interfere with this study
4. Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area
5. Having disorder of the healing
(whatever the considered area)
6. Having a rhinitis, allergic conjunctivitis or rhinosinusitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
dermatological safety of
investigational products
|
Baseline, 1day, 2 days and 8day |
|
|
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)
|
15/12/2016 |
| Date of Study Completion (India) |
05/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Single Application, semi
occlusive, Closed Patch Test is conducted to measure the irritation potential
of cosmetic products on the skin.
Objective: To evaluate
the dermatological safety of investigational products by primary irritation
patch test on healthy human volunteers of varied skin types.
Duration of study: 8
days study
Kinetics:
T0 (Evaluation of test sites by Dermat
and Subject,
Patch
application), T on
evaporation of products, T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat and
Subject post 30 minutes of patch removal), T2(Evaluation
of test sites by Dermat and Subject post 24 hrs of patch
removal),
T8 (Evaluation of test sites by Dermat and Subject post 1 week of
patch removal and tracking the positive cases)
Population 24 healthy
subjects(12 males + 12 females) The subjects are selected on the
basis of skin types:
3 males + 3 females for
dry skin
3 males + 3 females for
oily skin
3 males + 3 females for
combination skin
3 males + 3 females for
normal skin
Products : Perfume Spray (4170 A),
Perfume Spray (4171 B), Soap (TSP 113-25B), Soap (TSP 113-24B), Soap (TSP
113-38A), Soap (TSP 113-40A), Soap (TSP 113- 70), Soap (TSP 113- 71), Soap (TSP
113- 44), Soap (TSP 112- 79), Soap (TSP 112 – 102), Soap (TSP 112 – 113), Soap
(TSP 112- 121), Soap (TSP 112- 74), Face Wash (L6125), Face Wash (FW5970), Skin
Leave-On (AAD- Trial 1), Skin Leave- On (AAN#Trial1), Skin Leave- On
(WBS#115/01), Skin Leave-On (HFG#116004).
Positive control: 3% SLS
The test area is checked
for erythema and oedema caused due to the products and
compared with
positive control |