| CTRI Number |
CTRI/2024/09/073276 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| 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 Products on skin ageing |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in wrinkles
& fine lines, improvement in smoothness, skin even tone, skin moisturisation, skin firmness,
elasticity, Trans Epidermal Water loss & skin Luminosity on healthy female subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF02-KD-JY24; Version: 01; Dated: 09/08/2024 |
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
|
| Kama Ayurveda Pvt Ltd. Corporate Office: 18th Floor, Max Towers, Sector 16 B, Noida – 201301 |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd. |
| Address |
Corporate Office: 18th Floor, Max Towers, Sector 16 B, Noida – 201301 |
| 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
crows feet wrinkles & having varied skin type & sensitive skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
K Sugandh body oil |
Product is applied on whole face and body, twice in a week for period of 28 days |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian female subjects
2. Healthy subjects
3. Skin is healthy on the studied anatomic unit
4. Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
5. Having varied skin type & sensitive skin type
|
|
| ExclusionCriteria |
| Details |
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
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. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less
5. than 6 months)
6. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6
7. months)
8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic
9. products or food products.
10. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes(the only medication permitted is paracetamol).
11. Having cutaneous hypersensitivity.
12. Having undergone a surgery requiring a general anaesthetic 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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in wrinkles
& fine lines, improvement in smoothness, skin even tone, skin moisturisation, skin firmness, elasticity, Trans Epidermal Water loss & skin Luminosity |
Baseline, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
13/09/2024 |
| 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="2"
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
|
OBJECTIVE: To evaluate the in-vivo efficacy and safety of
a skin care formulation in terms of reduction in wrinkles & fine lines,
improvement in smoothness, skin even tone, skin moisturisation, skin firmness, elasticity,
Trans Epidermal Water loss & skin Luminosity on healthy female subjects.
The evaluation is performed using: Subject Self
Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Corneometry, Tewametry, Cutometry, Chromametry, Expert
Evaluation, Illustrative Images of whole face & ¾ th face under diffused
light
The study lasts 28 days following the first application
of the test product on the whole face.
POPULATION: 33 female subjects will be selected for the
study.
The subjects selected for this study are healthy females,
aged between 30 and 60 years old, having crow’s feet wrinkles & having varied
skin type & sensitive skin type with 1:1 ratio |