| CTRI Number |
CTRI/2025/05/087031 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Other |
|
Public Title of Study
|
The Study to check the safety and effectiveness of product on human volunteers |
|
Scientific Title of Study
|
To evaluate and compare the in vivo safety and efficacy of Skin Care Formulation versus Untreated control in terms of the Skin Moisturization or Hydration, Skin pH, Skin Brightness, Skin elasticity, Transepidermal Water Loss and Skin Glow on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HD02-BJ-AL25; Version: 01; Dated: 09/05/2025 |
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
|
| Bajaj Consumer Care Ltd
Registered Office: Old Station Road, Sevashram Chouraha,
Udaipur - 313 001 (Rajasthan).
Corporate Office: 1231, Solitaire Corporate Park, 151,
M Vasanji Marg. Opp Apple Heritage, Chakala,
Andheri (E), Mumbai - 400 093.
|
|
|
Primary Sponsor
|
| Name |
Bajaj Consumer Care Ltd |
| Address |
Registered Office: Old Station Road, Sevashram Chouraha,
Udaipur - 313 001 (Rajasthan).
Corporate Office: 1231, Solitaire Corporate Park, 151,
M Vasanji Marg. Opp Apple Heritage, Chakala,
Andheri (E), Mumbai - 400 093.
|
| Type of Sponsor |
Other [Non-government company ] |
|
|
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 |
Bajaj Almond drops Nourishing Body Lotion with Almond Oil (K02B) |
20 µl of the test product will be applied to randomized 3×3 cm² sites on the right forearm, left forearm, and area around the elbow. Each site will be compared against an adjacent untreated control site, and the product will be gently spread using a finger cot (approximately 15 rubs) and left uncovered for absorption.Water should not be applied on site for 72 hours. |
| Comparator Agent |
Untreated control site |
Another site of 3 × 3 cm² marked on the inner forearm, left forearm, and area around the elbow is kept as an untreated control site. No product application is done on the untreated control site. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Indian or Asian female subjects
2.Healthy subjects
3.Skin is healthy on the studied anatomic unit
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
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin Moisturization or Hydration, Skin pH, Skin Brightness, Skin Elasticity, Transepidermal Water Loss and Skin Glow |
Baseline, 15 minutes, 30 minutes, 24 Hours, 48 Hours and 72 Hours after product application |
|
|
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)
|
26/05/2025 |
| 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="15" |
|
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 versus Untreated control in terms of the Skin Moisturization/Hydration,
Skin pH, Skin Brightness, Skin Elasticity, Transepidermal Water Loss and Skin
Glow on healthy human subjects
The evaluation will be performed using, Subject Self Evaluation (SSE), Dermatological Evaluation for Cosmetic Acceptability, Corneometry, Skin pH metry, Tewametry , Glossymetry, Denolite, Chromametry, Cutometry
POPULATION- 33 Female
subjects will be selected for the study. The
subjects selected for this study will be healthy females, aged between 18 and 40 years old, having dry skin type.
STUDY DURATION- 72 hours
following the first application of the product. |