| CTRI Number |
CTRI/2024/04/065604 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking 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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q55-ZC-MH24; Version: 01; Dated:26/03/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
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 |
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,Personal Care] |
|
|
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 healthy skin on the studied anatomic area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline Solution - Negative control |
A single application of about 0.04ml of 0.9% Isotonic Saline, is applied under occlusion for 24hrs on the subjects back. |
| Comparator Agent |
1% Sodium Lauryl Sulphate (SLS) - Positive control |
A single application of about 0.04ml of 1% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back |
| Intervention |
13-116C |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
141-166C |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
141-168C |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
15-084 |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back |
| Intervention |
15-135A |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back |
| Intervention |
15-157A |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
15-157B |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
15-157C |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
15-157D |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
17-026) |
A single application of about 0.04ml of product is applied under semi-occlusion for 24hrs on the subjects back. |
| Intervention |
180-67 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Comparator Agent |
3% Sodium Lauryl Sulphate (SLS) - Positive control |
A single application of about 0.04ml of 3% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back |
| Intervention |
BB-CC-13905-B032S2D |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
CC-13905-BO362SD |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
CC-14116-B02311D |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
CC-14294-B24422D |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Comparator Agent |
Distilled water - Negative control |
A single application of about 0.04ml of distilled water is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
TSP 131-153 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
TSP 145-29 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
TSP 145-30 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
TSP 145-36 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
| Intervention |
TSP 145-39 |
A single application of about 0.04ml of 8% w/w of product prepared in distilled water, is applied under occlusion for 24hrs on the subjects back. |
|
|
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 who have not participated in a similar investigation in the past eight weeks. |
|
| 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="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2024 |
| Date of Study Completion (India) |
25/04/2024 |
| 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, Semi-occlusive and closed occlusive patch study. Objective: To evaluate the dermatological safety of investigational products through primary irritation patch test on healthy human volunteers. Duration of study: 9 days [3days and T8 (Evaluation of test sites by Dermatologist and Subject post 1 week of patch removal) visit is scheduled to monitor follow up reactions] Population 26 healthy subjects(13 males + 13 females) |