| CTRI Number |
CTRI/2022/06/043465 [Registered on: 23/06/2022] Trial Registered Prospectively |
| Last Modified On: |
26/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of test products on skin |
|
Scientific Title of Study
|
"To evaluate the 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 |
| D01-6Q48-ZC-JE22: Version No.: 01; Dated: 13/06/2022 |
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 – West, Mumbai – 400013,MAHARASHTRA, INDIA
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 – West, Mumbai – 400013,MAHARASHTRA, INDIA
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@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. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel – West, Mumbai – 400013,MAHARASHTRA, INDIA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel – West, Mumbai – 400013,MAHARASHTRA, INDIA |
|
|
Primary Sponsor
|
| Name |
ITC LIMITED ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial area, I Phase, Peenya Bengaluru, 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 |
| Dr Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
MASCOT-SPINCONTROL India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel – West, Mumbai – 400013,MAHARASHTRA, INDIA
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 varied skin types |
|
|
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 |
Perfume Spray
(14-017A) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-017B) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-017C) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-017D) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-017E) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-018A) |
The product contain volatile substance. 1cm2
disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-018B) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Perfume Spray
(14-019) |
The product contain volatile substance. 1cm2 disc of Whatman no. 3 filter paper will be placed on the back of subjects. 20 microlitre of product will be loaded on that, after evaporation 20microlitre of product will be loaded again. after evaporation the site will be occluded with aluminium finn chambers at T0 visit . This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
Rinse-off (HW26) |
The product is rinse off product. 8% w/w solution of the investigational products 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 |
Surface Cleaner
(ITC-HCL-022-
044A) |
The product is leave on product. the product 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 |
Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period |
|
| ExclusionCriteria |
| Details |
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 |
|
|
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 and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/06/2022 |
| Date of Study Completion (India) |
06/07/2022 |
| 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)
|
Completed |
| 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 (Product A to Product H) & occlusive (Product I, J
& Controls), 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 |