| CTRI Number |
CTRI/2023/11/059460 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of safety of products |
|
Scientific Title of Study
|
To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q50-ZC-OR23: Version: 01; Dated: 19/10/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC LIMITED, ITC Life Sciences and Technology Centre,No. 3, st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA. |
|
|
Primary Sponsor
|
| Name |
ITC LIMITED |
| Address |
ITC Life Sciences and Technology Centre,No. 3, st Main Road, Peenya Industrial Area, I Phase Peenya, Bangalore – 560058, INDIA. |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA |
02243349191
raji@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 |
with sensitive skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline Solution - Negative control |
0.9% Isotonic Saline Solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
1% Sodium Lauryl Sulphate (SLS) - Positive control |
1% Solution of SLS is prepared in distilled water and is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (145-72(B)): Product A |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (145-73): Product B |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (169-58): Product C |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (169-61): Product D |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (169-63): Product E |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (169-64): Product F |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (183-01): Product G |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (183-06): Product H |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (184-39): Product I |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (184-40): Product J |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (186-08): Product K |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (DFBWHSTT-01): Product L |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (DFSGACTT-02): Product M |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (DFSGASPP-01): Product N |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse off (SM162 – 33): Product O |
The product is rinse off product.8% w/w solution of the investigational product is prepared in distilled water. The prepared sample is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit .This is a single application and the occluded patch is removed after 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Female and male Asian Indian subjects.
2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
3)Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
4)For females: Urine pregnancy test (UPT) need to done. |
|
| ExclusionCriteria |
| Details |
1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.
2) Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area.
3)Having healing disorder in the concerned area.
4)Having rhinitis, allergic conjunctivitis, or rhino sinusitis.
5) Having an allergy to perfumes and/or preservatives in cosmetic products.
6)Having an allergy to plaster / adhesives used in plaster.
7) Having a food allergy.
8)Having a cardiovascular pathology that requires beta blocking treatments.
9)Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
10)Taking a retinoid-based treatment by general or oral route.
11)Taking specific treatment on the back.
12) Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
13)Having miliaria (prickly heat) on the back.
14) Presenting too many neavi on the back.
15) Having high pilosity on the back. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
Baseline,0 hrs,24 hrs & 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2023 |
| Date of Study Completion (India) |
16/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Single Application, Closed & Occlusive Patch Test is conducted to measure the irritation potential of cosmetic products on the skin. Objective: To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers with sensitive skin. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermat and Subject, Patch application), T on patch Application Day, T+30mins post patch application, T1(Patch removal, Evaluation of test sites by Dermat), 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 35 healthy subjects(17 males + 18 females) The distribution of volunteers as per skin type will be as follows: Sensitive Combination skin : 4 Females + 4 Males Sensitive Dry skin – 4 Females + 4 Males Sensitive Oily skin – 5 Females + 5 Males Sensitive Normal skin – 4/5 Females + 4/5 Males |