| CTRI Number |
CTRI/2021/08/035607 [Registered on: 12/08/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [N/AP] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and efficacy of skin care formulation |
|
Scientific Title of Study
|
To evaluate the in vivo efficacy and safety of a skin care formulation in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles on healthy male and female subjects. |
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF06-KD-JE21; Version: 01; Dated: 17/07/2021 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
Mascot Spincontrol India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400013
India |
| Phone |
022-43349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| The study will be conducted at Mascot Spincontrol, Mumbai India. |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| 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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
022-43349191
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 |
Volunteers with uneven skin tone and dull skin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1: Kumkumadi Biphase Serum
Group 2: Kumkumadi Biphase Serum and Rejuvenating Night Cream |
For Group 1: Apply the test product twice a day once in the morning; once at night (10-15 minutes before going to bed) for the period of 28 days.
For Group 2:Apply the test Product B once a day at night , after application of product A on whole face 10-15
minutes before going to bed for the period of 28 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
Having dull skin and uneven skin tone
Having pigmentary spot on the face
Having Crows feet wrinkle of grade 2
Having visible under eye dark circle |
|
| ExclusionCriteria |
| Details |
Having started, changed or interrupted one hormonal treatment (hormonal contraception,
Hormone Replacement Therapy) during the past 3 months
Having started, changed or stopped her tobacco consumption (for smokers consuming more
than 10 cigarettes per day) in the previous 6 months
Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food
and/or not smoke in the two hours preceding the measurements
Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
amiodarone, metals, minocycline…) in the previous 6 months
• Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C,
beta-carotene…)
Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or having
applied self-tanning products in the week preceding the start of the study
Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde,
isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study
Having applied products with a depigmenting/ whitening action (hydroquinone or
derivates…) in the 4 weeks preceding the start of the study.
Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice,
pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months
Having a suntanned skin on the studied areas which could interfere with the evaluations of
the study
For males, having not shaved their beard 24 hours prior to the day of measurement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the product in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles |
T0, T14 days and T28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
T0, T14 days and T28 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
02/09/2021 |
| 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
|
NIL |
|
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 skin even tone, reduction in
pigmentation (dark spots), radiant skin, skin brightening, skin moisturization,
minimize fine lines and wrinkles, smooth skin and helps in reduction of dark
circles on healthy male and female volunteers
Duration of study: 28 days study
Kinetics: T0, T+14 days and T+28 days
Population: Group 1 36 volunteers
Group 2: 36 volunteers
|