| CTRI Number |
CTRI/2024/10/075030 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Product on skin hydration |
|
Scientific Title of Study
|
To evaluate and compare the invivo safety and efficacy of Skin Care Formulations versus Untreated control in terms of the moisturization & skin water barrier function on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD01-ZI-SR24; Version: 01; Dated: 03/10/2024 |
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
|
| Emami Limited.
13 BT Road
Kolkata – 700056
West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Emami Limited. |
| Address |
13 BT Road
Kolkata – 700056
West Bengal, India |
| Type of Sponsor |
Other [Fast-Moving Consumer Goods] |
|
|
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 dry skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boroplus Ayurvedic Antiseptic Cream |
On 33 subjects of group A, The Product is applied on
marked site of 3 x 3 cm2 on
inner forearm once at site and
left at is for 24 hours.
Application is done only one
time. |
| Intervention |
Boroplus Ayurvedic Antiseptic Cream |
On 33 subjects of group B, The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 24 hours. Application is done only one time. |
| Intervention |
Product C |
On 33 subjects of group A, The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 24 hours. Application is done only one time. |
| Intervention |
Product D |
On 33 subjects of group B, The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 24 hours. Application is done only one time. |
| Comparator Agent |
Untreated control site on inner
forearm. |
On all the 66 subjects of group A & B, a site of 3 x 3 cm2 marked on inner forearm is kept as untreated control site. No product application is done on
untreated control site. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin moisturization & skin water barrier function |
Baseline, 30 Minutes, 8 Hours, 24Hours |
|
|
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)
|
19/10/2024 |
| 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="0"
Days="8" |
|
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 versus Untreated
control in terms of the moisturization & skin water barrier function on
healthy female subjects.
The evaluation will be performed using:Subject Self
Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Corneometry,
Tewametry
The study will last 24 hours, following the application of
the product.
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 C
Group B :- Product B & Product D
The subjects selected for this study will be healthy females
aged between 18 and 40 years, having dry skin type.
STUDY DURATION
Duration: 24 hours following the application of the product. |