| CTRI Number |
CTRI/2024/09/073335 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of product on skin hydration |
|
Scientific Title of Study
|
To evaluate and compare the in-vivo safety and efficacy of Skin Care Formulation verses Untreated Control in terms of skin moisturization, skin brightness, skin softness, skin smoothness and skin barrier function on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD02-CK-JY24; Version: 01; Dated: 18/07/2024 |
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
|
| Vedistry Pvt Ltd. 21, Evergreen Industrial estate, Shakti mills lane, Off Dr. E Moses Road, Mahalaxmi, Mumbai- 400011. |
|
|
Primary Sponsor
|
| Name |
Vedistry Pvt Ltd. |
| Address |
21, Evergreen Industrial estate, Shakti mills lane, Off Dr. E Moses Road, Mahalaxmi, Mumbai- 400011. |
| Type of Sponsor |
Other [FMCG] |
|
|
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 |
Moha Body Yogurt |
The Product is applied on marked site of 3 x 3 cm2 on inner forearm once at site and left at is for 72 hours. Application is done only one time. |
| Comparator Agent |
Untreated control site on inner forearm. |
another 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 brightness, skin softness, skin smoothness and skin barrier function |
Baseline, 30 Minutes, 48 Hours, 72 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
10/09/2024 |
| 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="10" |
|
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 Formulation
verses Untreated Control in terms of skin moisturization, skin brightness, skin
softness, skin smoothness and skin barrier function on healthy female subjects
The evaluation is performed using: Subject Self
Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Corneometry, Tewametry, Chromametry
The study lasts 72 hours following the first
application of the product on the forearm.
POPULATION- 33 Female subjects will be selected for
the study.
The subjects selected for this study are healthy
females, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION- Duration: 72 hours following the first
application of the product.
STUDY DESIGN - Single blind study, Comparative study, Subjects
serve as their own reference for the intra-group comparison (evaluation of the
efficacy on time of product) and do not serve as their own reference for the
inter-group comparison (comparison of the efficacy of the test product A with
Untreated Control). |