| CTRI Number |
CTRI/2024/08/073049 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| 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 Products on skin ageing |
|
Scientific Title of Study
|
To evaluate the safety and efficacy of a skin care formulation in terms of skin firmness, elasticity, hydration,brightness, skin shine glow and reduction in pore size on healthy human subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HF01-XY-AL24; Version: 02; Dated: 12/08/2024 |
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
|
| Herbalife HNL Business Services India Pvt. Ltd. Ground Floor, Tower C, Prestige Shantiniketan, Krishnarajapuram Hobli, Bengaluru South Taluk, Bangalore KA 560048 |
|
|
Primary Sponsor
|
| Name |
Herbalife |
| Address |
HNL Business Services India Pvt. Ltd. Ground Floor, Tower C, Prestige Shantiniketan, Krishnarajapuram Hobli, Bengaluru South Taluk, Bangalore KA 560048 |
| 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 Mohit Lalvani |
MASCOT-SPINCONTROL India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
mohit.CTRI@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa- Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with varied skin types and having visible pores on face |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Toner |
The Product is applied on whole face, frequency of application is twice in a day for the period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian / Asian male and female subjects
2)Healthy subjects
3)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
4)Having varied skin types (ideally equal representation of all 4 skin types – Oily, Normal,
Dry and Combination)
5)Having visible pores on face as determined by the dermatologist.
|
|
| ExclusionCriteria |
| Details |
1)For females: 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)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6)Having a progressive asthma (either under treatment or last fit in the last 2 years)
7)Being epileptic.
8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
10)Under 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).
11) Having cutaneous hypersensitivity.
12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13)Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
14) Having applied a cosmetic product (included make-up) on the studied areas during study
evaluations. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Skin firmness, elasticity, hydration, brightness, skin shine/glow and reduction in
pore size |
Baseline, Immediate after product application, 2 hours, 14 days, 28 days |
|
|
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)
|
07/09/2024 |
| 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-The objective of this study will be to evaluate
the safety (acceptability) and efficacy of a skin care formulation in terms of
skin firmness, elasticity, hydration, brightness, skin shine/glow and reduction
in pore size on healthy human subjects for product
The evaluation is performed using: Subject Self
Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological
Evaluation: Efficacy, Corneometry, Glossymeter, Chromametry, Skin pH metry, Cutometry,
VisioFace (Images Analysis for Pore size through cross polarized light)
The study duration is for 28 days (+ 1 day) following the
first application of the product on the whole
face.
POPULATION- 36 (18 male and 18 female) healthy subjects will
be included for the study.
They will be aged between 18 and 45 years (both
inclusive) of varied skin types (ideally equal representation of all 4 skin
types – Oily, Normal, Dry and Combination (dry or normal in some areas and oily in
others) and having visible pores on face as evaluated by the dermatologist.
STUDY DESIGN- This is
a single arm study, Non-Comparative study, Subjects will serve as their own
references. |