| CTRI Number |
CTRI/2025/09/094884 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [COSMECEUTICALS] |
| Study Design |
Other |
|
Public Title of Study
|
Study to Check Safety and Effectiveness of Skin Care Products |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of cosmetic formulation in Conferring skin benefits in healthy human Indian subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF02-ZC-AT25; Version: 01; Dated: 02/09/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niharika Salian |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
niharika@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC LIMITED |
| Address |
ITC LIMITED
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, 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 Niharika Salian |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai
MAHARASHTRA |
02243349191
niharika@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 |
Subjects with Acne prone skin, uneven skin tone |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moisturizer Premix FMP-04 |
This product will be applied on randomized test site on forearm on Day 2 visit. |
| Comparator Agent |
NIL |
NA |
| Intervention |
Product BMD-03 |
The product is applied on whole face, forearms (twice a day) and body (daily once) for a period of 28 days. |
| Intervention |
Product MHJ-02 |
The product is applied on whole face, forearms (twice a day) and body (daily once) for a period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Acne prone skin and uneven skin tone.
2. Subjects with no cuts, abrasions, wounds, injuries, allergies, tattoos, scars, henna or any other
developments / artefacts on face and forearms that can impact the measurements.
3. Subjects willing to abide by the study protocol, laid restrictions and consenting to visit the site for
periodic assessments on the scheduled dates. |
|
| ExclusionCriteria |
| Details |
1. For Females:Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having refused to give his/her assent by not signing the consent form and Informed consent form
3. Taking part in another study liable to interfere with this study
4. Being known diabetic case
5. Known asthma case
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Being known thyroid case
8. Being epileptic.
9. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
10. Known case of hypersensitivity.
11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin cleansing, Sebum and Acne Control, overall skin parameters |
Pre use, Post 1 use, 1 day post use, Post 7 days, 14 days, 21days and 28 days of use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
10/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief Summary: The study aims at assessing the safety and skin benefitting efficacy of the investigational products over a 28 day use duration by healthy human Indian adults with periodic assessments pre and post use, 1 day post use, Post 1 week, 2 weeks, 3 weeks and 4 weeks of Use. Assessments:(a) Non invasive Insturmental measurements for skin
hydration, barrier, Sebum, imaging.
(b) Dermatologists Assessment of product safety, tolerance and
skin benefitting efficacy and
(c) Subjects self assessment of product safety, tolerance and skin
benefitting efficacy.
|