| CTRI Number |
CTRI/2024/02/062693 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulations] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy check of skin care product |
|
Scientific Title of Study
|
PRIMARY OBJECTIVE: To evaluate and compare the in-vivo efficacy and safety of two skin regimes in terms of reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot and on healthy female subjects.
SECONDARY OBJECTIVE: To evaluate the subject feedback for product efficacy in terms of clear skin (basis reduction in dark spots) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF01-IT-OR23; Version: Final 01;25/01/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Incnut Lifestyle Retail Pvt. Ltd. G3, Ground floor, Modren profound Tech Park,
Kondapur, Serilingampally, Ranga Reddy District,
Hyderabad-500084 |
|
|
Primary Sponsor
|
| Name |
Incnut Lifestyle Retail Pvt Ltd |
| Address |
G3, Ground floor, Modren profound Tech Park,
Kondapur, Serilingampally, Ranga Reddy District,
Hyderabad-500084 |
| 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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai
MAHARASHTRA |
02243349191
raji@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 |
having normal skin type with Age Related Dark Spots, dry skin and dull and tanned skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Regime 1 |
This regime has 5 products in it, cleanser, 2 serum, 2 gel. These products will be applied on whole face once in a day for the period of 56 days. |
| Intervention |
Regime 2 |
This regime has 2 products in it, serum & lotion. serum to be applied twice in a day on dark spots and lotion to be applied once in a day on whole face for the period of 56 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects
2)Having dry skin.
3)Having normal skin type with Age Related Dark Spots.
4)Having dull and tanned skin. |
|
| ExclusionCriteria |
| Details |
1)Being pregnant or breastfeeding or having stopped to
breastfeed in the past three months.
2)Having refused to give her
assent by 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 a progressive asthma (either under treatment or last fit in
the last 2 years)
6)Being epileptic
7)Having non stabilized thyroid problems (requirement of a stabilized
treatment for at least 6 months)
8)Having cutaneous hypersensitivity
9)Having a diagnosed or highly probable allergy to one or several
compounds of the cosmetic products or food products or to latex
10) 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 (the
only medication permitted is paracetamol)
11)Having undergone a surgery requiring a general anaesthetic of
more than one hour in the past 6 months.
12)Having changed her cosmetic habits in the 14 days preceding the
start of the study on the studied anatomic unit
13)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
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot |
Baseline, 48 hours, 14 days, 28 days, 56 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clear skin (basis reduction in dark spots) |
Baseline, 48 hours, 14 days, 28 days, 56 days. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/02/2024 |
| 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
|
PRIMARY OBJECTIVE: To evaluate and compare the in-vivo efficacy and safety of two skin regimes in terms of reduction in dark spots (Lightens the pigmentation of selected dark spots-age spots), improvement in skin moisturization upto 48 hours, improvement in skin brightening , improvement in skin firmness, elasticity, skin radiance, skin glow, skin softness, prevention of water loss from skin (TEWL parameter) and tan reduction, reduction in fine line and wrinkles and clear skin in terms of reduction in dark spot and on healthy female subjects. SECONDARY OBJECTIVE: The seconday objective of the study will be to evaluate the subject feedback for product efficacy in terms of clear skin (basis reduction in dark spots).
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Cutometry, Corneometry, Mexametry, Chromametry, CLBT (Color, Luminosity, Brightness, Transparency), Tewametry, Illustrative photographs of face under diffused light
The study lasts 56 days following the first application of the test products on the whole face.
72 Females subjects will be selected for the study. The subjects selected for this study are healthy females, aged between 35 and 55 years old, having normal skin type with Age Related Dark Spots (at least 3.5mm in size), dry skin and dull and tanned skin. The study will be conducted in 2 groups. Group A: This group will include 36 female subjects using Regime (Product A to Product E). Group B: This group will include 36 female subjects using Regime (Product F and Product G).
|