| CTRI Number |
CTRI/2025/04/085889 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
The Study to assess safety and effectiveness of product on human volunteers |
|
Scientific Title of Study
|
To evaluate the in vivo efficacy and safety of a skin care regime in terms of reduction in hyperpigmentation, Acne PIH, improvement in Skin brightness, skin tone evenness and skin texture on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-QF02-UL-MH25; Version: Final 01; Dated: 28/03/2025 |
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
|
| Satiya Nutraceuticals Private Limited
Building No B3 2G, Asmeeta Textile Park MID,IND Kalyan[1] Bhiwandi Rd KON,
Bhiwandi, Thane, Maharashtra, 421311 |
|
|
Primary Sponsor
|
| Name |
Satiya Nutraceuticals Private Limited |
| Address |
Building No B3 2G, Asmeeta Textile Park MID,IND Kalyan[1] Bhiwandi Rd KON, Bhiwandi, Thane, Maharashtra, 421311 |
| 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(L81.0 - Post-inflammatory hyperpigmentation) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Regime(Placebo Cleanser+ Placebo Toner+ Placebo serum+ Placebo moisturizer) |
Placebo regime has 4 Products in it all the products are applied by all the subjects, Product 1 is placebo Cleanser which is used twice in a day on whole face in morning and evening. Product 2 is placebo Toner which is used twice in a day on whole face in morning and evening . Product 3 is placebo serum which is used twice in a day on whole face in morning and afternoon and product 4 is placebo moisturizer which is used twice in a day on whole face in morning and afternoon.for the period of 28 days.The whole regime is used by all the subjects for the period of 28 days. |
| Intervention |
Test Regime(Pineapple Depigmentation Juicy Cleanser+Pineapple Exfoliation Fruity Toner+Pineapple Depigmentation Dewy serum+Pineapple Depigmentation Smoothie moisturizer) |
Test regime has 4 Products in it all the products are applied by all the subjects, Product 1 is Pineapple Depigmentation Juicy Cleanser which is used twice in a day on whole face in morning and evening. Product 2 is Pineapple Exfoliation Fruity Toner which is used twice in a day on whole face in morning and evening. Product 3 is Pineapple Depigmentation Dewy serum which is used twice in a day on whole face in morning and afternoon and product 4 is Pineapple Depigmentation Smoothie moisturizer which is used twice in a day on whole face in morning and afternoon The whole regime is used by all the subjects for the period of 28 days. |
|
|
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
5)Having visible Acne PIH
6)Having dull skin |
|
| 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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hyperpigmentation (Acne PIH), improvement in Skin brightness, skin tone evenness and skin texture |
Baseline, Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
04/05/2025 |
| 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 - To evaluate the in-vivo efficacy and
safety of a skin care regime in terms of reduction in hyperpigmentation (Acne
PIH), improvement in Skin brightness, skin tone evenness and skin texture on
healthy female subjects for product coded:
The evaluation will be performed using, Subject
Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Mexametry, Chromametry, Corneometry
POPULATION-72 (36 for test regime and 36 for
placebo regime) 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 (at least one spot of 3mm or more) and dull skin.
STUDY DURATION- 28 days following the first
application of the test product.
|