| CTRI Number |
CTRI/2022/05/042724 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Safety and Efficacy of Product |
|
Scientific Title of Study
|
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in acne &
acne PIH, improvement in skin texture (i.e., softness & smoothness), reduction in pore size, reduction
in sebum content, improvement in skin brightenesss on healthy male & female subjects. SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms of balancing skin pH and
improvement in skin plumpness on healthy male & female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-SF02-KD-MY22; Version: Final 01; Dated: 11/05/2022 |
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. 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. 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. 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.
,
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. 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. 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
oily & mixed oily skin (having acne prone skin) and combination skin type with acne lesions,
blackhead, whiteheads & visible pores. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIMRAH FACE PACK: Product A |
Product will be applied thrice in a week on whole face. for period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Indian male and 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 Having oily & mixed oily skin (having acne prone skin) and combination skin type with acne lesions, blackhead, whiteheads & visible pores
|
|
| ExclusionCriteria |
| Details |
1 For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give her/his assent by signing the consent form
3 Taking part in another study liable to interfere with this study
4 Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
5 Being asthmatic.
6 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
7 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 (the only medication permitted is paracetamol).
8 Having cutaneous hypersensitivity.
9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
11 Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
12 Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted)
13 Refusing to follow the restrictions below during the study: For Females: Do not take part in any family planning activities leading to pregnancy and breastfeeding, Do not take part in another study liable to interfere with this study, Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol), Do not change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit., During the study: Do not use other cosmetic products than the tested products to the studied areas, Do not use hair oil ,The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted)
14 In the 6 previous months ,Having started, changed or stopped a hormonal treatment (hormonal contraception, cyproterone acetate …), Having taken an oral retinoid-based treatment
15 In the previous month, Having undergone a physical (phototherapy, laser ..) or chemical (peeling) 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 (gluconate of zinc) or spironolactone
16 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 (e.g. skin cleansing, exfoliation, scrub, mask …), Having a suntanned skin on the studied areas which could interfere with the evaluations of the study
17 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 (e.g. skin cleansing, exfoliation, scrub, mask …), Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …), 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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in acne &
acne PIH, improvement in skin texture (i.e., softness & smoothness), reduction in pore size, reduction
in sebum content, improvement in skin brightenesss |
15 minutes, 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Balancing skin pH and
improvement in skin plumpness |
15 minutes, 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)
|
27/05/2022 |
| 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 reduction in acne &
acne PIH, improvement in skin texture (i.e., softness & smoothness), reduction in pore size, reduction
in sebum content, improvement in skin brightenesss on healthy male & female subjects. SECONDARY OBJECTIVE
To evaluate the in-vivo efficacy of a skin care formulation in terms of balancing skin pH and
improvement in skin plumpness on healthy male & female subjects.
Duration of study: 28 days study Kinetics: T0, T+15 minutes
after product
application and T+28 days Population: 36 (18 Females & 18 Males) volunteers The evaluation is
performed using:
1
Subject Self Evaluation
2
Dermatological Evaluation: Cosmetic
Acceptability
3
Dermatological Evaluation: Efficacy
4
Sebumetry â–ª Chromametry
5
Skin pH metry
6
Illustrative Images of the whole &
3/4th face under diffuse light |