| CTRI Number |
CTRI/2021/02/031594 [Registered on: 26/02/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of products |
|
Scientific Title of Study
|
To assess the sensitization potential of skin care and hair care formulations on healthy human subjects. |
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q11-KD-FR21; Version: 01; Dated: 10/02/2021 |
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, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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, INDIA
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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 |
3rd Floor, Kohinoor Estate,
Sun Mill compound,
Lower Parel,
Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle,
Jungpura Extension,
New Delhi – 110014. |
| 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. |
3rd Floor, Kohinoor Estate,
Sun Mill compound,
Lower Parel,
Mumbai, INDIA
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
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 |
1.Extra virgin Coconut Oil (010 / 20-21)
2.Organic Sweet Almond Oil (ARY/O/16828)
3.Organic Moringa Oil (MO05)
4.Jwalini Face Oil (JFOT - 001)
5.Abhiroopa Face Oil (AFOT - 001)
|
For product 1 to 5 the products are leave on product, so are placed directly in the aluminum chambers of the patch and applied on the back of the volunteer.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
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 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, Poriasis, 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 |
| Safety assessment of products |
T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application
T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal
T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading
14 DAYS RESTING PHASE
T21 – Patch Application
T22 – Patch Removal
T23 - 24 hour post patch removal grading
T24 - 48 hour post patch removal grading
T25 - 72 hour post patch removal grading
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
28/02/2021 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/AP |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: The objective of this study is to evaluate the sensitization potential of Skin Care formulations on healthy human subjects Population of 120 healthy subjects (60 males + 60 females) The test area is checked for erythema and oedema caused due to the products.
T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading 14 DAYS RESTING PHASE T21 – Patch Application T22 – Patch Removal T23 - 24 hour post patch removal grading T24 - 48 hour post patch removal grading T25 - 72 hour post patch removal grading |