| CTRI Number |
CTRI/2022/08/044895 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| 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 skin care formulation |
|
Scientific Title of Study
|
Evaluation of irritation potential of Skin Care Formulations on healthy human subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q22-TE-JY22; Version: 01; Dated: 28/07/2022 |
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
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 |
TTK Healthcare limited Consumer product division |
| Address |
PROTECTIVE DEVICES DIVISION
Research and Development No.3, Thiruneermalai Road,
Chrompet, Chennai-600 044, Tamil Nadu, 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 – West, Mumbai – 400013,MAHARASHTRA, INDIA
Mumbai
MAHARASHTRA
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 |
Normal skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MsChief Classic Natural Lubricant (MCLUF-002) |
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. |
| Intervention |
MsChief Tea &
Peach Natural
Lubricant
(MCLTP-003)
|
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. |
| Intervention |
MsChief Vanilla
& Citrus Natural
Lubricant
(MCLVC-001) |
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. |
| Intervention |
MsChief Ylang
Ylang Natural
Lubricant
(MCLYY-003)
|
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. |
| Comparator Agent |
Negative Control
(0.9% Isotonic
saline solution)
|
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 |
Positive Control
(1% w/w SLS) |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Human Subjects
2) is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
3) 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, Psoriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having 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,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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: To evaluate the irritation potential on healthy human subjects of skin Care Formulations. Duration of study: 8 days study Kinetics: T0 (Evaluation of test sites by Dermatologist, Patch application) T1(Patch removal, Evaluation of test sites by Dermatologist T2(Evaluation of test sites by Dermatologist 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 test area is checked for erythema and oedema caused due to the products and compared with positive control.
|
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