| CTRI Number |
CTRI/2021/05/033366 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 on skin |
|
Scientific Title of Study
|
Evaluation of irritation potential of skin care and hair care formulations on healthy human subjects |
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q14-KD-MH21; Version: 01; Dated: 02/04/2021 |
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 (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.
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 (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
|
| Name |
Address |
| Not Applicable |
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. |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel,
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 |
EHAFC (EHAFCT-002) : Product A
RBANC (RSBNCT-001) : Product B
KBAFS (KBAFST-001) : Product C
RJHCL (RJHCT-001) : Product D |
For Product, A, B and C Measure 0.04 ml (40 μl) of test samples with the help of 1 ml syringe.
Transfer the test products on previously numbered Aluminium Finn Chamber, with the help of 1 ml syringe.
The Finn chambers with the loaded products will then be taped onto the back of subjects.
For Product D:
8% w/w solution of the investigational product will be prepared by weighing 2g of the product and dissolving it in distilled water and making up the final weight to 25g.
0.04 ml or 40 μl of the prepared sample will be loaded onto the filter paper disc with the help of
1 ml Micropipette.
The Finn chamber with the product loaded filter paper discs will then be taped onto the back of
subjects. |
| Comparator Agent |
Isotonic Solution: Negative Control SLS: Positive Control |
For Negative Control: 40 μl of 0.9% Isotonic Saline Solution is transferred to previously numbered Aluminium Finn Chamber with an appropriate sized disk of Whatman no. 3 filter paper with the help of Micropipette. For Positive Control: Sodium Lauryl Sulphate solution: 1% w/w solution of SLS in distilled water will be prepared.
•0.04 ml or 40 μl of the SLS solution will be loaded onto a Whatman filter paper disc, placed in clean Aluminum Finn Chamber. The Finn chamber with the loaded 0.9% Isotonic Saline solution will be taped onto the back of subjects |
|
|
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, 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 |
| Safety assessment of products |
0 hrs, 24 hrs & 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)
|
10/05/2021 |
| 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="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Single Application Closed Patch test is conducted to measure the irritation potential of cosmetic products on the skin Objective: To evaluate the irritation potential on healthy human subjects of Skin and Hair 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. |