| CTRI Number |
CTRI/2022/04/042231 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
25/04/2022 |
| 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 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 improvement in
hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness
& elasticity, reduction in pore size, reduction in sebum content on healthy male & female subjects.
SECONDARY OBJECTIVE:
To evaluate the in-vivo efficacy of a skin care formulation in terms of reduction in transepidermal water
loss, balancing skin pH and improvement in skin plumpness on healthy male & female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-SF01-KD-AL22; Version: Final 01; Dated: 19/04/2022 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. 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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. Mumbai (Suburban) MAHARASHTRA 400013 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 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 |
With Oily to Mixed oily and Combination skin type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMC Face Cream: Product A |
Application will be done on whole facer, twice a day, in morning and at night for the period of 28 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Indian male and female subjects
2)Healthy subjects
3)Between 18 and 45 years of age.
4)Skin is healthy on the studied anatomic unit
5)Having oily & mixed oily skin and combination skin type with acne lesions, blackhead, whiteheads & visible pores |
|
| ExclusionCriteria |
| Details |
1)For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2)Having refused to give his/her assent by signing the consent form
3)Taking part in another study liable to interfere with this study
4)In the 6 previous months
Having started, changed or stopped a hormonal treatment,
Having taken an oral retinoid-based treatment.
5)In the previous month
Having undergone a physical or chemical treatment for acne,
Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment,
Having had an oral treatment with a base of cimetidine, zinc or spironolactone
6)In the 2 previous weeks
Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin,
Having had oral or local antibiotic treatment for acne,
Having had beauty treatment,
Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
7)Refusing to follow the restrictions below during the study
Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin ,
Do not have beauty treatment,
Do not start, change or stop a hormonal treatment,
Do not start a local or general treatment acting on seborrhoea,
Do not expose himself/herself to the sun,
Strictly avoid sun exposure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in
hydration, reduction in acne, improvement in skin texture (i.e., softness & smoothness), skin firmness
& elasticity, reduction in pore size, reduction in sebum content |
BASELINE, 10 minute after Product application, 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
reduction in transepidermal water
loss, balancing skin pH and improvement in skin plumpness |
BASELINE, 10 minute after Product application, 28 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)
|
05/05/2022 |
| 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:
PRIMARY
OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care
formulation in terms of improvement in hydration, reduction in acne,
improvement in skin texture (i.e., softness & smoothness), skin firmness
& elasticity, reduction in pore size, reduction in sebum content on healthy
male & female subjects. • SECONDARY OBJECTIVE To evaluate the in-vivo efficacy
of a skin care formulation in terms of reduction in transepidermal water loss,
balancing skin pH and improvement in skin plumpness on healthy male &
female subjects.
Duration
of study: 28 days study
Kinetics:
Screening, T0, T+10 minutes after Product application 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 Corneometry
5 Cutometry
6 Sebumetry
7 Tewametry
8 Skin pH metry
9 Illustrative Images of the whole & 3/4th face
under diffuse light
|