| CTRI Number |
CTRI/2025/08/092677 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
A study to check if the product is safe and works well on human volunteers |
|
Scientific Title of Study
|
To evaluate and compare the in vivo safety and efficacy of skin care formulations versus Untreated control in terms of the moisturisation and skin water barrier function on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD04-ZI-JY25; Version: 01; Dated: 28/07/2025 |
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
|
| Emami Limited
13, B.T. Road
Kolkata - 700056
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Emami Limited |
| Address |
13, B.T. Road
Kolkata - 700056
West Bengal, India
|
| 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 dry skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BPDKL Lotion |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 48 hours. |
| Intervention |
BPIRL Lotion |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 48 hours. |
| Intervention |
BPSJL Lotion |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 48 hours. |
| Intervention |
BPSLM Cream |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 48 hours. |
| Intervention |
BPSPF Cream |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncovered for absorption. Water should not be applied on site for 48 hours. |
| Comparator Agent |
Untreated control site |
Another site of 3 × 3 cm² marked on the inner forearm is kept as an untreated control site. No product application is done on the untreated control site. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Indian or Asian female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
4.Subject having dry skin type. |
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give her/his 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 a progressive asthma (either under treatment or last fit in the last 2 years)
6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
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 (the only medication permitted is paracetamol)
10. Having cutaneous 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 anesthetic of more than one hour in the past 6
months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| skin moisturisation and skin water barrier function |
Baseline, 30 minutes, 24 hours, 48 hours after product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/08/2025 |
| 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="0"
Days="20" |
|
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 and compare the in-vivo safety and efficacy of skin care formulations in terms of skin moisturisation and skin water barrier function on healthy female subjects.
The evaluation will be performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Corneometry, Tewametry
POPULATION: 66 females subjects will be selected for the study. The study will be conducted in 2 groups 33 females subjects in each group
Group A: - Product A, Product B & Product C
Group B: - Product D, Product E
The subjects selected for this study will be healthy females, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION: 48 hours following the first application of the products. |