| CTRI Number |
CTRI/2024/07/071089 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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 cosmetic product on skin |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function on healthy female subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-HF01-FA-JE24; Version: Final 01;03/07/2024 |
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
|
| Mountain valley springs India pvt. ltd.E-46 & 47, I.A, Bahadrabad, Haridwar, Uttarakhand-249402, INDIA |
|
|
Primary Sponsor
|
| Name |
Mountain valley springs India pvt. ltd. |
| Address |
E-46 & 47, I.A, Bahadrabad, Haridwar, Uttarakhand-249402, INDIA |
| 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 loose skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Regime |
Regime has two products. both products are applied on whole face once in day for period of 15 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 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. Subjects having loose skin.
|
|
| 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. 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 cutaneous hypersensitivity
10. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
11. Following a chronic or intermittent medicinal treatment comprising any of the following products:aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
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 |
| Improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin water barrier function |
Baseline, 30 minutes after product application, Day 7, Day 15 |
|
|
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)
|
02/08/2024 |
| 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 Yet Recruiting |
| 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
|
To
evaluate the in-vivo efficacy and safety of a skin care regime in terms of
improvement in Skin Firmness, skin elasticity, Skin Moisturization, and skin
water barrier function on healthy female subjects
The
evaluation will be performed using: Subject Self Evaluation, Dermatological
Evaluation: Cosmetic Acceptability, Corneometry, Cutometry, Tewametry, Illustrative
Images of the whole face under diffuse light
The
study lasts for 15 days following the first application of the product.
POPULATION:
36 Female Subjects will be selected for the study.
The
subjects selected for this study will be healthy females, aged between 30 to 55
years, having loose skin. |