| CTRI Number |
CTRI/2025/09/094497 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Baby care products] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check the safety of baby care products on human |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the sensitization potential of Baby Care formulations on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q03-M3-AT25; Version: 01; Dated: 14/08/2025 |
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
|
| Mother Sparsh Baby care Pvt. Ltd
Plot no 330, Industrial Area Phase 1,
Panchkula, Haryana - 134113
|
|
|
Primary Sponsor
|
| Name |
Mother Sparsh Baby care Pvt. Ltd |
| Address |
Plot no 330, Industrial Area Phase 1, Panchkula, Haryana - 134113 |
| Type of Sponsor |
Other [Cosmetic/Personal Care 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 |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Having healthy skin on studied anatomic unit |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mother Sparsh After Bite Turmeric Balm |
Patch application as per BIS standard.0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Cold Pressed Coconut Oil for Babies |
Patch application as per BIS standard. 0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Natural insect Repellent |
Patch application as per BIS standard. 0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Natural Vapour Complete Cold relief roll on |
Patch application as per BIS standard.0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Nourishing Hair Oil For Babies |
Patch application as per BIS standard. 0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Nourishing Massage Oil for Babies |
Patch application as per BIS standard. 0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Intervention |
Mother Sparsh Tummy Roll On |
Patch application as per BIS standard. 0.04 ml or 40 microlitre of the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
| Comparator Agent |
Negative Control
(0.9% Isotonic saline solution)
|
Patch application as per BIS standard. 0.9% Isotonic Saline Solution is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 visit. There will be 10 time (9 time in induction phase and 1 time in challenge phase) application and the occluded patch is removed after every 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthy Human Subjects
2) Skin should be healthy on the studied anatomic unit |
|
| ExclusionCriteria |
| Details |
1. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2. Having refused to give his or her assent by not signing the consent form
3. Taking part in another study liable to interfere with this study
4. Being diabetic.
5. Being asthmatic.
6. 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).
7. Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
9. Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months.
10. Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11. The day of the patch application: no cosmetic product must be used (test site clean with water only). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitization potential |
Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "213"
Final Enrollment numbers achieved (India)="213" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
03/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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
|
The objective of this study will be to evaluate
the sensitization potential of Baby formulations
on healthy human subjects The evaluation is performed using: Dermatological Evaluation: Human Repeat Insult Patch Test Method Total duration of the study: 40 days following the first application of product. Kinetics: Induction phase with 21 visits( T0, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, T12, T13, T14, T15, T16, T17, T18, T19 and T20) then resting phase of 14 days and 5 days of Challenge phase( T21, T22, T23, T24 & T25) The study is conducted in 3 phases: 1. Induction Phase, 2. Resting Phase,3. Challenge Phase Induction phase is of 21 days and in which 9 repeated applications of patches are carried out which are removed after 24 hours of application and evaluated after 24 hours of patch removal. Resting phase is of 14 days in which no application of any patch is done in order to develop sensitization to the test product. In Challenge phase only one patch is applied which is removed after 24 hours and evaluated after 24 hours 48 hours and 72 hours Number of volunteers: 220 (110 male+110 female) subjects |