| CTRI Number |
CTRI/2024/09/073443 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| 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 invivo efficacy and safety of a skin care formulation in terms of reduction in wrinkles
and fine lines, density of dark spots, improvement in skin smoothness, plumpness, skin even tone, skin
moisturization, trans epidermal water loss, skin brightening, skin firmness and skin elasticity on
healthy female subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-RF01-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 & fine lines, dark spots |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
K ELA FACE OIL |
Product is applied on whole face once at night 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. Healthy subjects
2. Skin is healthy on the studied anatomic
3. Having Crows feet wrinkle
4. Having at least 1 dark spot (age spot).
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, density of dark spots, improvement in skin smoothness, plumpness, skin even tone, skin
moisturization, trans epidermal water loss, skin brightening, skin firmness & skin elasticity |
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)
|
14/09/2024 |
| 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, density of dark spots, improvement
in skin smoothness, plumpness, skin even tone, skin moisturization, trans
epidermal water loss, skin brightening, skin firmness & skin elasticity on healthy
female subjects.
The
evaluation is performed using: Subject Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry,
Corneometry, Tewametry, Mexametry, Cutometry, Illustrative Images of the whole
face & 3/4th face under diffuse light
The study
lasts for 28 days following the first application of the product.
POPULATION:
33 female subjects will be selected for the study.
The
subjects selected for this study will be healthy females aged between 30 to 60 years,
having crow’s feet wrinkles & fine lines, dark spots (age spot) &
having varied skin type & sensitive skin type with 1:1 ratio. |