| CTRI Number |
CTRI/2025/08/093228 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Personal Care and Hygiene Products] |
| Study Design |
Other |
|
Public Title of Study
|
Clinical trial to check the safety of personal care products |
|
Scientific Title of Study
|
Evaluation of the irritation potential of Skin and Hygiene Care formulations on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q27-ST-JY25; Version: 01; Dated: 13/08/2025 |
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
|
| Sirona Hygiene Pvt. Ltd.
Unit no 101-103, First floor,
Tower-A, Pioneer urban square, Sector 62
Golf course extension road, Gurugram
Pin-122101
|
|
|
Primary Sponsor
|
| Name |
Sirona Hygiene Pvt. Ltd. |
| Address |
Unit no 101-103, First floor,
Tower-A, Pioneer urban square, Sector 62
Golf course extension road, Gurugram
Pin-122101
|
| Type of Sponsor |
Other [Personal Care and Hygiene Products] |
|
|
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- Institutional 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 |
Intimate wipes |
A single application of a• Approximately 1×1 cm2 cut area of the product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Negative Control (0.9% Isotonic saline solution) |
A single application of about 0.04ml of 0.9% Isotonic Saline, is applied under occlusion for 24 hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Panty liners |
A single application of a• Approximately 1×1 cm2 cut area of the product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Comparator Agent |
Positive Control (1% w/w SLS) |
A single application of about 0.04ml of 1% SLS, prepared in distilled water is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
| Intervention |
Sweat pads |
A single application of a• Approximately 1×1 cm2 cut area of the product is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is for 24 hours and removed after that. |
|
|
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/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 anesthesia of more than one hour in the past 6 months.
10) Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dermatological safety / Irritation potential on skin |
Baseline,0 hrs,24 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
29/08/2025 |
| 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="9" |
|
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
the irritation potential on healthy human subjects of Skin and Hygiene Care Formulations Kinetics: T0(before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal ), T8 days (T+1 week after 0 hour of patch removal) Population: 26healthy Minor subjects (13 males + 13 females) . The test area is checked for erythema and oedema caused due to the products and compared with positive control |