| CTRI Number |
CTRI/2022/01/039184 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy of skin care formulation |
|
Scientific Title of Study
|
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot) & radiant skin on healthy male & female subjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in hydration on healthy male & female subjects
|
| Trial Acronym |
N/AP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-NF07-KD-DR21; Version: 01; Dated: 16/12/2021 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
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 |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| 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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound,
Lower Parel West, Mumbai Mumbai (Suburban) MAHARASHTRA
Mumbai
MAHARASHTRA
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 |
Volunteers having dull skin, pigmentary spots, crow’s feet wrinkles, uneven skin tone and visible
under eye dark circles |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FACE OIL:Product A |
Application will be carried out on face, once in day for the period of 28 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
Having dull skin and uneven skin tone
Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas
Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas
Having visible under eye dark circle
|
|
| ExclusionCriteria |
| Details |
Having started, changed or interrupted one hormonal treatment during the past 3 months
Having started, changed or stopped her tobacco consumption in the previous 6 months
Having consumed caffeine-based products, 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 in the previous 6 months
Taking oral supplements with major or minor effect on whitening of skin
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 in the 2 weeks preceding the start of the study
Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study
Having undergone physical and/or chemical treatments of the spots 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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate of efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin |
T0, T14 days and T28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
efficacy of a skin care formulation in terms signs of ageing: minimize fine
lines, smooth skin texture, reducing dark circles and improvement in hydration |
T0, T14 days and T28 days |
|
|
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)
|
07/01/2022 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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: PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and
safety of a skin care formulation in terms of even skin tone, reduction in
pigmentation (dark spot) & radiant skin on healthy male & female
subjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a
skin care formulation in terms signs of ageing: minimize fine lines, smooth
skin texture, reducing dark circles and improvement in hydration on healthy
male & female subjects Duration of study: 28 days study Kinetics: T0, T+14 days and T+28 days Population: 36 (18 Females & 18 Males) volunteers The evaluation is performed using: 1. Subject’s Self Evaluation, 2. Dermatological Evaluation: Cosmetic Acceptability, 3. Dermatological Evaluation: Efficacy 4. Chromametry 5. Corneometry 6. CLBT (Color, Luminosity, Brightness, Transparency) |