| CTRI Number |
CTRI/2022/01/039692 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [skin care formulations] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation and Comparison of safety & Efficacy of four skin care formulations |
|
Scientific Title of Study
|
To evaluate & compare the in-vivo safety and efficacy of four skin care formulations in terms of reduction of wrinkles on healthy female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PLT-XXX-RF-166-NR21; Version:01; Dated: 11/12/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA Mumbai (Suburban) MAHARASHTRA 400013 India
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
|
The study will be conducted at Mascot Spincontrol, Mumbai India. |
|
|
Primary Sponsor
|
| Name |
MERCK PERFORMANCE MATERIALS PVT LTD |
| Address |
Godrej One, 8th floor, Pirojshah Nagar,
Eastern express highway, Vikroli (E),
Mumbai- 400079, 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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Mascot Spincontrol India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA |
02243349191
raji@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 |
The subjects selected for this study are healthy females aged between 35-55 years of age having
crows feet wrinkles of grade 2-4 & having visible dry skin and wrinkles. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Age Miracle Cream
with Ronacare ASC
III & Ronacare
RenouMer : Product A |
1 gm of Product will be applied once in a day on whole face for period of 56 days |
| Intervention |
Loreal Paris Revitalift
Hyaluronic Acid: Product D |
4-5 drops of Product will be applied once in a day on whole face for period of 56 days |
| Comparator Agent |
N/AP |
N/AP |
| Intervention |
Olay 7 in 1 cream: Product B |
1 gm of Product will be applied once in a day on whole face for period of 56 days |
| Intervention |
Skinlift Serum with Ronacare
Luremin: Product C |
4-5 drops of Product will be applied once in a day on whole face for period of 56 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Indian Asian female subjects
Healthy subjects no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup
Between 35 and 55 years of age.
Skin is healthy on the studied anatomic unit free of eczema, wounds, inflammatory scar
Subject having Crows feet wrinkle of grade 2 and above according to the Bazins atlas. using Page number 40 of Skin Ageing Atlas
Subject having visible dry skin.
|
|
| ExclusionCriteria |
| Details |
Having started, changed or stopped a hormonal treatment in the past 3 months.
Having taken an oral retinoid-based treatment in the past 6 months
Having taken a local retinoid-based treatment on the studied areas in the previous month
Having had beauty treatment in the previous week
Having practiced water activities in the previous week.
Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
Having practiced intensive sports during the day prior to the T0 measurements
Having wounds, Scars, sunburns, tattoos and piercing on test site.
Having hair on test site.
Having applied another product than water on the studied areas in the morning of the T0 measurements
Having had an intensive UV exposition on the inner forearm prior to T0 measurements
Having used cosmetic product on the studied area during 24 hours prior to T0 measurements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the safety and efficacy of a skin care formulation in terms of reduction of wrinkles |
T0, T28days, T56days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of all the test products in terms of reduction in density of dark spots &
improvement in skin moisturization, skin firmness and skin brightening |
T0, T28days, T56days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
29/01/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 & compare the in-vivo safety and efficacy of four skin care formulations in terms of reduction of wrinkles on healthy female subjects.
The evaluation is performed using: 1. Subject Self Evaluation (SSE) 2. Dermatological Evaluation: Cosmetic Acceptability 3. Dermatological Evaluation: Efficacy 4. Chromameter 5. Cutometer 6. Corneometer
The study will last 56 days following the first application of the product
Kinetics: Screening , T0, T+28 days and T+56 days |