| CTRI Number |
CTRI/2025/04/085211 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy assessment of product in reducing Skin Tan and enhancing skin brightening on Indian volunteers. |
|
Scientific Title of Study
|
Evaluation of the in vivo safety and efficacy of cosmetic formulations in conferring tan reduction and skin lightening or brightening benefits on Indian Volunteers.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF01-ZC-FR25; Version: Final 01; Dated: 09/04/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@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
|
| ITC LIMITED
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA
|
|
|
Primary Sponsor
|
| Name |
ITC LIMITED |
| Address |
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA
|
| Type of Sponsor |
Other [Fast-Moving Consumer Goods] |
|
|
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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@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 |
Skin Tan, Dark spots or Marks |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Sunscreen Cream |
Product to be applied on Face and Forearms twice daily when indoors and every 40m on face and Sun exposed body parts when exposed to Sun.
Frequency: Twice daily when indoors, about 3-4 times when out in Sun.
Study Duration: 28 days
Intervention Duration: The product is to be left on skin till the next occasion of skin cleansing. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy subjects
2.Skin that is healthy on the studied anatomic unit
3.Subjects with visible skin Tan on face and dorsal forearm, at least 1 shade darker than the Sun protected upper volar arm as per MASCOT’s Indian skin shade card.
4.Subjects with a Chromameter L value in the range of 40 to 60 on cheeks, and L value on volar upper arm of at least 2 units higher than the L value on forehead and dorsal forearm.
5.Atleast 20 Subjects with few dark spots (other than melasma or chloasma or rosacea or birth mark or moles or warts or chronic pigmentation) on face.
6.Volunteer who exhibit good tolerance to the investigational product with no signs of sensitivity.
7.Having Varied skin types
8.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)Subjects who have started, changed or stopped a hormonal treatment (hormonal contraception, Hormonal Replacement Therapy, thyroid …) in the past 3 months
2)Subjects who have taken an oral retinoid-based treatment in the past 6 months.
3)Subjects having had a local retinoid-based treatment on the studied areas in the previous month.
4)Subject having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week.
5)Subjects having practiced water activities (swimming pool, sauna, hammam) in the previous week
6)Subjets having drunk or eaten caffeine based products (coffee, cola, tea, …), alcohol, highly spiced food or smoked in the two hours preceding the measurements.
7)Subject having practiced sport the day of start of the study.
8)subjects who are either pregnant or nursing.
9)Subjects who have participated in similar kind of investigation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in skin tan and related hyperpigmentation (Dark spots or blotches or patches, uneven tone).
2)Improvement in skin Lightening, Brightness or Radiance. |
Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in skin parameters like Color or complexion, Even tone, Hydration or Moisturization, Clarity, Texture, Softness or Suppleness, Skin brightness or Radiance or Glow, Smoothness compared to baseline as per Dermatologist’s assessment, Subjects’ self-assessment or Instrumental measurements |
Baseline, Post 1 product application, Post 24 hours after 1st product application, Day 14, Day 21 and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2025 |
| Date of Study Completion (India) |
28/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|