| CTRI Number |
CTRI/2025/11/097647 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
Study to test if a skin care product helps improve skin firmness, moisture, and reduces wrinkles and dark spots |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of a skin care formulation in terms of anti- aging effect that is improvement in skin firmness, skin moisturisation, reduction in wrinkles and fine lines and reduction in dark spot that is age spot on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF01-I8-NR25; Version: 01; Dated: 11/11/2025 |
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
|
| Alvio Pharmaceuticals Pvt Ltd / UNCAP D 10, Signature 2, Sarkhej Sanand Crossroads, Sarkhej, Ahmedabad-382210, Gujarat |
|
|
Primary Sponsor
|
| Name |
Alvio Pharmaceuticals Pvt Ltd / UNCAP |
| Address |
D 10, Signature 2, Sarkhej Sanand Crossroads, Sarkhej, Ahmedabad-382210, Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 wrinkles and dark spot (age spot). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
uncap REWIND ADVANCED AGE REPAIR CREAM (CSH25020) |
The product is applied on the whole face once in a day at night for the period of 56 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian Male and Female subjects
2)Skin is healthy on the studied anatomic unit
3)Having crows feet wrinkles and dark spot (age spot).
|
|
| 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 |
| Anti-aging effect i.e. improvement in skin firmness, skin moisturisation, reduction in wrinkles and fine lines & reduction in dark spot (age spot) |
Baseline, Day 14, Day 28 and Day 56 |
|
|
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)
|
29/11/2025 |
| 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="4"
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, Corneometry,
Mexametry, Digital Photographs
POPULATION:36 (18 males & 18 females) subjects will be
selected for the study.
The subjects selected for this study will be healthy females & males,
aged between 35 to 55
years, having crow’s feet wrinkles and dark spot (age spot).
STUDY DURATION : 56 days following the first application of the
product. |