| CTRI Number |
CTRI/2022/05/042920 [Registered on: 30/05/2022] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy assessment of Product |
|
Scientific Title of Study
|
to evaluate in-vivo safety and efficacy of skin care formulation
on healthy female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PLT-XXX-RF-191-AL22; Version: Final 01; Dated: 27/04/2022 |
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
|
| Mascot Spincontrol India Pvt. Ltd. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel, Mumbai – 400013, INDIA Mumbai (Suburban) MAHARASHTRA 400013 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
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
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 |
having
visible melasma, crows feet wrinkles of grade 2 and above. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Skin Brightening Cream |
1 gm 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 |
1 Indian or Asian female subjects
2 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.
3 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria
4 Subjects having visible melasma, having crows feet wrinkles of grade 2 and above.
|
|
| 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 and Informed consent form
3 Taking part in another study liable to interfere with this study
4 Being known diabetic case
5 Known asthma
6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
7 Being known thyroid case
8 Being epileptic.
9 Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
10 Known case of hypersensitivity.
11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13 Having changed their cosmetic habits except those required by the protocol 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 48 hours prior study
Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroid…) in the past 3 months.
16 Having taken an oral retinoid-based treatment in the past 6 months
17 Having taken a local retinoid-based treatment on the studied areas in the previous month
18 Having had beauty treatment (e.g. scrub, manicure, self-tanning product …) in the previous week
19 Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.
20 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
21 Having practiced intensive sports during the day prior to the T0 measurements
22 Having wounds, Scars, sunburns, tattoos and piercing on test site.
23 Having hair on test site.
24 Having applied another product than water on the studied areas in the morning of the T0 measurements
25 Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.
26 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 |
| Reduction of melasma, Products safety on skin |
28 days, 56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in skin moisturization, skin
firmness and skin brightening & reduction in density of wrinkles and fine lines |
28 days, 56 days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
03/06/2022 |
| 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 the in-vivo safety and efficacy
ofskin care formulations on healthy female subjects
Primary Objective:
To study the safety and efficacy of a skin care formulation in terms of
reduction of melasma.
Secondary Objective:
To study the efficacy of all the test products in terms of improvement in skin
moisturization, skin firmness and skin brightening & reduction in density
of wrinkles and fine lines.
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
7 Illustrative
photographs of whole face under diffused ligh
The study will last 56 days following the first
application of the product
Kinetics: Screening , T0, T+28
days and T+56 days |