| CTRI Number |
CTRI/2025/10/096541 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to check the safety and effect of a skin care product on dark spots and skin tone. |
|
Scientific Title of Study
|
To evaluate the in vivo safety and efficacy of a skin care formulation in terms reduction in hyperpigmentation that is age spots and skin even tone on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-2A-SR25; Version: 01; Dated: 22/09/2025 |
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
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
|
| AU Naturel Beauty Pvt. Ltd (NEUDE). 39a, Triveni Gardens Rd, Gadpur Farm, DLF Farms, New Delhi - 110030 |
|
|
Primary Sponsor
|
| Name |
AU Naturel Beauty Pvt. Ltd (NEUDE). |
| Address |
39a, Triveni Gardens Rd, Gadpur Farm, DLF Farms, New Delhi - 110030 |
| 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 age spots, at least one spot of 3mm or more |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Skin care formulation |
The Product is applied on whole face twice in a day morining and night for the period of 56 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Healthy subjects
2)Skin is healthy on the studied anatomic unit
3)Having age spots, at least one spot of 3mm or more |
|
| ExclusionCriteria |
| Details |
1. 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 |
| Reduction hyperpigmentation (age spots) and skin even tone |
Baseline, Day28. 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)
|
07/11/2025 |
| 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="3"
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
|
OBJECTIVE : The objective of this study will be to evaluate the in vivo safety and efficacy of a skin care formulation in terms reduction hyperpigmentation (age spots) and skin even tone on healthy female subjects coded: The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy , Chromametry, Mexametry The study lasts for 56 days following the first application of the product. POPULATION : 36 females subjects are selected for the study. The subjects selected for this study are healthy females aged between 30 and 55 years, having age spots, at least one spot of 3mm or more. STUDY DURATION : 56 days following the first application of the product. |