| CTRI Number |
CTRI/2024/12/077981 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Sensitization Potential of Skin Care Formulations on Human Subjects |
|
Scientific Title of Study
|
The objective of this study will be to evaluate the sensitization potential of Skin Care formulations on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D01-6Q01-1P-DR24; Version: 01; Dated: 05/12/2024 |
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
|
| Panacea Biotec Pharma Ltd.
Ambala Chandigarh Road,
P.O. Lalru-140501, Punjab |
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Pharma Ltd. |
| Address |
Ambala Chandigarh Road,
P.O. Lalru-140501, Punjab |
| 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 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 apparently healthy skin on Test area |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Isotonic Saline Solution - Negative control |
10 time (9 time in induction phase and 1 time in challenge phase) application of about 0.04ml of 0.9% Isotonic Saline Solution, under occlusion for 24hrs on the subjects back. |
| Intervention |
Rash cream |
10 time (9 time in induction phase and 1 time in challenge phase) application of about 0.04ml of test product under occlusion for 24hrs on the subjects back. |
| Intervention |
Wash |
10 time (9 time in induction phase and 1 time in challenge phase) application of about 0.04ml of 8% w/w of product prepared in distilled water, under occlusion for 24hrs on the subjects back. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Female and male Asian Indian subjects.
2. Healthy Human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) |
|
| 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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitization potential |
Baseline, 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)
|
18/12/2024 |
| 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
|
The objective of this study will be to evaluate the
sensitization potential of Skin Care 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 |