| CTRI Number |
CTRI/2021/12/038377 [Registered on: 02/12/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [not applicable] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety assessment of skin care formulations |
|
Scientific Title of Study
|
Evaluation of irritation potential of Beard Care & Skin Care formulations on healthy human subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q08-MW-OR21: Version: 01; Dated: 08/11/2021 |
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
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
Mumbai
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 |
3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel
Mumbai (Suburban)
MAHARASHTRA
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| The Study will be conducted at Mascot Spincontrol, Mumbai, India |
|
|
Primary Sponsor
|
| Name |
Mosaic wellness pvt ltd |
| Address |
Mosaic Wellness Pvt Ltd, 7th Skyline Icon, Chimatpada, Marol naka, Andheri, Mumbai, 400059 |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| 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
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 |
| Comparator Agent |
1) Positive Control: Sodium Lauryl Sulphate (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 |
| Intervention |
1. Beard gro plus Tonic: Product A |
40μl of test Product is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is a single application and the occluded patch is removed after 24 hours. |
| Comparator Agent |
2) 0.9% Isotonic Saline Solution - Negative control |
40 μl of 0.9% Isotonic Saline Solution is transferred on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is a single application, and the occluded patch is removed after 24 hours. |
| Intervention |
2. Beardgro Tonic: Product B |
40μl of test Product is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
3. Dark max Tonic: Product C |
40μl of test Product is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is a single application and the occluded patch is removed after 24 hours. |
| Intervention |
4. CLEAR 2% Salicylic acid face wash: Product D |
8% w/w solution of the investigational products is prepared in distilled water and 40μl of the solution is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is a single application, and the occluded patch is removed after 24 hours. |
| Intervention |
REJUV Vitamin C face wash: Product E |
8% w/w solution of the investigational products is prepared in distilled water and 40μl of the solution is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. 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, 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 product |
T0 (before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal), T8 days (1 week after 0 hour of patch removal) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2021 |
| Date of Study Completion (India) |
15/12/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |