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CTRI Number  CTRI/2023/04/051906 [Registered on: 24/04/2023] Trial Registered Prospectively
Last Modified On: 06/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [skin care formulations]  
Study Design  Single Arm Study 
Public Title of Study   Safety & Efficacy check of cosmetic product 
Scientific Title of Study   Primary Objective:To assess the efficacy of two skin care formulations, post routine sun exposure in terms of moisturization, skin radiance, skin brightening, improvement in even skin tone on healthy female subjects. Secondary Objective:To assess the efficacy of two skin care formulations, post routine sun exposure in terms of skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum on healthy female subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-NF02-ZI-MH23; Version:01; Dated: 13/04/2023   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
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 
Phone  02243349191  
Fax    
Email  raji@mascotspincontrol.in  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Lalvani 
Designation  Study Director 
Affiliation  MASCOT-SPINCONTROL India Pvt. Ltd. 
Address  Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.

Mumbai
MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  mohit.CTRI@gmail.com  
 
Source of Monetary or Material Support  
MASCOT-SPINCONTROL India Pvt. Ltd. , Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai. 
 
Primary Sponsor  
Name  EMAMI LTD. 
Address  A Wing, 701, 7th Floor Express Zone, Western Express Highway, Opposite to Oberoi Mall, Goregaon (East), Mumbai – 400 062 
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
MAHARASHTRA 		 02243349191

raji@mascotspincontrol.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethos- An Institutional Ethics committee (Mumbai)   Approved 
Ethos- An Institutional Ethics committee (Mumbai)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  having dull skin with dark spots of acne PIH, under eye dark circle, oily to mixed oily skin type & dark to wheatish skin  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fairness Cream 1  Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days  
Intervention  Fairness Cream 2  Product will be applied on the whole face , twice a day application in morning and evening for the period of 21 days 
Comparator Agent  Nil  Not applicacble 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Indian 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 Between 18 and 35 years of age.
4 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
5 Having dull skin with dark spots (acne PIH)
6 Having under eye dark circle
7 Having dark to wheatish skin (L between 45 to 55)
8 Having oily to mixed oily skin type
9 Having daily routine involving atleast 2 hours sun exposure
 
 
ExclusionCriteria 
Details  1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
2 Having refused to give her assent by not 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 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
6 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
10 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
11 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)
12 Refusing to follow the restrictions below during the study: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 their 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, The day of the measurements: No test product must be used (only face cleaned with water is accepted)
13 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months
14 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
15 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
16 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months.
17 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
18 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
19 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
20 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
21 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study


22 Refusing to follow the restrictions below during the study:Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy), Do not start a medicinal treatment which could lead to hyper pigmentation, Do not take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…), Do not consume caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements, Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products, Do not use products or techniques or surgery with a depigmenting / whitening action, Do not expose herself to the sun by respecting a strict photo-protection.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
moisturization, skin radiance, skin brightening, improvement in even skin tone  Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours) 
 
Secondary Outcome  
Outcome  TimePoints 
firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebum  Baseline, 10 minutes, 4 hours, 8 hours, 10 hours, 7 days (10 minutes, 4 hours, 8 hours, 10 hours), Day 14(10 minutes, 4 hours, 8 hours, 10 hours), Day 21(10 minutes, 4 hours, 8 hours, 10 hours) 
 
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)   27/04/2023 
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 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  

OBJECTIVETo evaluate & compare the in-vivo safety and efficacy of two skin care formulations post routine sun exposure in terms of moisturization, skin radiance, skin brightening, improvement in even skin tone, skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/sebum on healthy female subjects

Primary Objective: To assess the efficacy of two skin care formulations, post routine sun exposure in terms of moisturization, skin radiance, skin brightening, improvement in even skin tone.

 Secondary Objective: To assess the efficacy of two skin care formulations, post routine sun exposure in terms of skin firmness, reduction in dark spots (acne PIH), reduction in under eye dark circles, skin oiliness/ sebum.

Product :Fairness Cream 1, Fairness Cream 2

The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Chromametry, Corneometry, CLBT (Color, Luminosity, Brightness, Transparency), Sebumetery, Mexametry, Tewametry, Cutometry, Expert Evaluation: Assessment of Transfer-Proof & Water-Proof Efficacy, Analysis of the skin color through cross polarized light , Illustrative Images of whole face & ¾ th face under Diffused Light

Total duration of the study: 21 days

Kinetics:Day 1 (T1)- T0, T+10 minutes (T2), T+4 hours (post sun exposure) (T3), T+8 hours (T4), T+10 hours (T5), Day 7 (T6)-T+7 days, T+10 minutes (T7), T+4 hours (post sun exposure) (T8), T+8 hours (T9), T+10 hours (T10), Day 14 (T11)- T+14 Days, Day 21 (T12)- T+21 Days, T+10 minutes (T13), T+4 hours (post sun exposure) (T14), T+8 hours (T15), T+10 hours (T16)

Product application: Twice a day, morning and evening

Number of volunteers: 72 (36 per product) female subjects.

 
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