| CTRI Number |
CTRI/2025/01/079148 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check Effectiveness and Safety of a products on human subjects |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity on healthy females subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF02-AG-DR24; Version: 01; Dated: 08/01/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| 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 |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Study Director |
| 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
|
| Anveya Living Private Limited - Haryana
Property no. 307, Sector-55,
Gurugram, Gurugram, Haryana, 122003 |
|
|
Primary Sponsor
|
| Name |
Anveya Living Private Limited - Haryana |
| Address |
Property no. 307, Sector-55,
Gurugram, Gurugram, Haryana, 122003 |
| Type of Sponsor |
Other [Non-government company ] |
|
|
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 |
having normal skin type with visible Acne PIH (L81.4 - Other melanin hyperpigmentation) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Regime(Cleanser + Serum + sunscreen) |
Products of placebo regime are applied on the whole face for the period of 28 days. Cleanser is applied twice in a day, serum is applied once and sunscreen is applied twice in a day. |
| Intervention |
Test Regime(Brightening pro cleanser+Brightening pro serum+Brightening pro sunscreen SPF 50+ PA++++) |
Products of test regime are applied on the whole face for the period of 28 days. Cleanser is applied twice in a day, serum is applied once and sunscreen is applied twice in a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects.
2)Healthy subjects.
3)Skin is healthy on the studied anatomic unit
4)Having normal skin type with visible Acne PIH. |
|
| 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 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 progressive asthma.
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 cosmetic products.
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 consumed caffeine-based products (coffee, cola, tea …),
alcohol, highly spiced foods and/or smoked in the two hours
preceding the measurements.
12. Having undergone a surgery requiring a general anaesthetic of
more than one hour in the past 6 months.
13. Having changed her cosmetic habits in the 14 days preceding
the start of the study on the studied anatomic unit
14. Having applied a cosmetic product (included make-up) or skin
care product on the studied areas the 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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hyper-pigmentation (Acne PIH), improvement in skin even tone, skin brightness, skin hydration, skin gloss & skin elasticity |
Baseline, Day 7, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
OBJECTIVE: To evaluate the in-vivo efficacy and safety of a
skin care regime in terms of reduction in hyper-pigmentation (Acne PIH),
improvement in skin even tone, skin brightness, skin hydration, skin gloss
& skin elasticity on healthy females subjects
The evaluation is performed using: Subject Self Evaluation, Dermatological
Evaluation: Safety, Mexametry, Chromametry, Corneometry, Glossymeter, Cutometry
POPULATION:72 (36 for test regime and 36 for placebo) female
subjects will be selected for the study.
The subjects selected for this study are healthy females,
aged between 18 and 40 years old, having normal skin type with visible Acne
PIH.
STUDY DURATION: 28 days following the first application of
the test product. |