| CTRI Number |
CTRI/2025/12/098921 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check if a skin care product is safe and helps reduce signs of ageing |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of a Skin care formulation in terms of antiaging reduction in fine lines and wrinkles, reduction in pigmentary patches, skin firmness, skin homogeneity and skin moisturisation on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF03-XC-NR25; Version: 01; Dated: 19/11/2025 |
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
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
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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| VLCC Personal Care Ltd. Magnum City Centre, Near Birla Navya Township, Sector-63A, Gurugram, Haryana 122011 |
|
|
Primary Sponsor
|
| Name |
VLCC Personal Care Ltd. |
| Address |
Magnum City Centre, Near Birla Navya Township, Sector-63A, Gurugram, Haryana 122011 |
| Type of Sponsor |
Other [Personal Care or Beauty Industry] |
|
|
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
Mumbai
MAHARASHTRA |
02243349191
niharika@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having crow’s feet, under eye, forehead and nasolabial wrinkles and fine lines, having dull skin, having dark spots and patchy skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
VLCLBOTOFLESRM628 |
The Product is applied on Whole face two times in a day for the period of 84 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian male and Female subjects
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit
4)Having crows feet, under eye, forehead and nasolabial wrinkles and fine lines, having dull skin, having dark spots and patchy skin
|
|
| 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
3)Taking part in another study liable to interfere with this study
4)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5)Having acne prone skin.
6)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
7)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
8)Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
9)Having cutaneous hypersensitivity.
10)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12)Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in fine lines and wrinkles, reduction in pigmentary patches, skin firmness, skin homogeneity and skin moisturisation |
Baseline, Day 14, Day28, Day 42, Day56, Day 70 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
21/12/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The evaluation will be performed using:Subject
Self Evaluation,
Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Cutometry,
Spectrophotometry, Corneometry, Mexametry
POPULATION:36 (18 male & 18 female) human subjects will be selected for the
study.
The subjects
selected for this study will be healthy male & females, aged between 25 to 55 years, having crow’s feet, under eye, forehead
and nasolabial wrinkles and fine lines, having dull skin, having dark spots and
patchy skin.
STUDY DURATION: 84 days following the first application of the product. |