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CTRI Number  CTRI/2023/02/049829 [Registered on: 17/02/2023] Trial Registered Prospectively
Last Modified On: 06/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmaceutical]  
Study Design  Single Arm Study 
Public Title of Study   Safety and efficacy check of Product on skin 
Scientific Title of Study   To evaluate the in-vivo efficacy and safety of a skin care regime in terms of skin brightening & skin radiance on healthy female subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-NF01-RT-DR22; Version: Final 01; Dated: 25/01/2023  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.

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. 3rd Floor, Kohinoor Estate, Sun Mill compound, Lower Parel Mumbai, MAHARASHTRA 400013 India 
 
Primary Sponsor  
Name  BRIGHT LIFECARE PVT. LTD. 
Address  The Presidency, Tower B, Second Floor, 46/4, M G ROAD, SECTOR-14, Opp. Girls Collage, GURUGRAM-122001. 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers with dull skin & wheatish to dark complexion 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HKVitals Vitamin E Face Moisturizer(6588):Product C  This is the third product of test regime. After application of product A & B take approx. 0.5 gm quantity of test product and apply on the whole face. Gently spread the test product in outward direction. The application is twice a day at morning & evening on whole face for the period of 28 days. 
Intervention  HKVitals Vitamin E Face Wash(6626):Product A  This is the first product of test regime. Take 0.5 gm quantity of test product on palm and massage all over the face then rinse with water and pat dry. The application is twice a day at morning & evening on whole face for the period of 28 days. 
Intervention  HKVitals Vitamin E Serum(6562):Product B  This is the second product of test regime.After application of product A, take 4-5 drops of test product and apply on whole face.Spread the test product in outward direction.The application is twice a day at morning & evening on whole face for the period of 28 days. 
Comparator Agent  Nil  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  The study will be conducted on subjects who will fulfill the following criteria:
1.Indian / Asian 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 to 35 years and above.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
5.Having dull skin.
6.Having wheatish to dark complexion  
 
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 signing the consent form
3.Taking part in another study liable to interfere with this study
4.Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
7.Being epileptic
8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9.Having cutaneous hypersensitivity
10.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
11. 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)
12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
14.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).
15.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 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 (only usual cleanser/soap is accepted)
- The day of the measurements: No test product must be used (only face cleaned with water is accepted)
16.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.
17.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months
18.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months
19.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
20.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
21.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
22.Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
23.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
24.Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
25.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 start an oral or local retinoid-based treatment
- 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 action.
- Do not practice water activities (swimming pool, sauna, hammam, balneotherapy).
- Do not practice sport the days of study.
- Do not expose yourself to the sun by respecting a strict photo-protection.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the in-vivo efficacy and safety of a skin care regime in terms of skin brightening & skin radiance on healthy female subjects.  Baseline, day 14 , Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not applicable 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/02/2023 
Date of Study Completion (India) 30/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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)  Completed 
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 regime in terms of skin brightening & skin radiance on healthy female subjects.

Duration of study: 28 days study

Kinetics: T0, T+14 days & T+28 days

Population: 36 Female volunteers

The evaluation is performed using:

- Subject Self Evaluation

- Dermatological Evaluation: Cosmetic Acceptability

- Chromametry

- CLBT (Color, Luminosity, Brightness, Transparency)

Product application : Application of test  regime containing 3 test products is twice a day at morning & evening on whole face for the period of 28 days.

Modalities of application for Product A:
Wet your face with water. Take 0.5 gm quantity of test product on palm and massage all over the face avoiding eye area. Rinse thoroughly with water and pat dry.
Modalities of application for Product B:
After application of product A take 4-5 drops of test product on palm and apply on whole face. Gently spread the test product in outward direction. Ensure that you don’t rub the product into your skin.
Modalities of application for Product C:
After application of product A & B take approx. 0.5 gm quantity of test product and apply dot wise on the whole face. Gently spread the test product using only fingers in outward direction. Ensure that you don’t rub the product into your skin.

 
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