| CTRI Number |
CTRI/2026/02/103687 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
Study to check the safety of cosmetic product on human volunteers |
|
Scientific Title of Study
|
Evaluation of the sensitization potential of Skin Care Formulation on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q08-TP-JR26; Version: 01; Dated: 05/02/2026 |
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
Mumbai
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
|
| Torrent Pharmaceuticals Limited
Torrent Research Center
Beside Kanoria Hospital
Nr. Indira Bridge,
Gandhinagar
Gujarat-382428, INDIA
|
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Limited |
| Address |
Torrent Research Center
Beside Kanoria Hospital
Nr. Indira Bridge,
Gandhinagar
Gujarat-382428, INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Samarth – Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with healthy skin on studied anatomic unit. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Negative Control
(Distilled Water)
|
0.04 ml or 40 microlitre of distilled water 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. The total study duration is 40 days, and each patch remains on the site for 24 hours. |
| Intervention |
Tedibar Ceramax Head to Toe Bodywash (TB003B) |
0.04 mL (40 microlitres) of an 8% w/w product solution prepared in distilled water is dispensed into the aluminium chambers of the patch and applied on the volunteers’ backs at the T0 visit. There will be a total of 10 applications (9 during the induction phase and 1 during the challenge phase). Each occluded patch will be removed after 24 hours. The total study duration is 40 days, and each patch remains on the site for 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
3)Having Photo type III to V |
|
| ExclusionCriteria |
| Details |
1)For female: Pregnant/nursing mothers
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)Having participated in study in past one month.
5)Being diabetic.
6)Being asthmatic.
7)Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol).
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/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).
12)Having Scars, excessive terminal hair or tattoo on the studied area.
13)Having Henna tattoo anywhere on the body (in case of studies involving hair dyes).
14)Having Dermatological infection/pathology on the level of studied area.
15)Having Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
16)Having any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
17)Having chronic illness which may influence the outcome of the study.
18)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
19)Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
|
|
|
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)= "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)
|
22/02/2026 |
| 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="5"
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
|
The objective of this study will be to evaluate the sensitization potential of skin care formulation 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 |