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CTRI Number  CTRI/2022/05/042747 [Registered on: 23/05/2022] Trial Registered Prospectively
Last Modified On: 02/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Evaluation of safety & Efficacy of skin care formulation  
Scientific Title of Study   The objective of this study will be to evaluate the efficacy and safety of a skin care formulation interms of reduction in appearance of wrinkles & fine lines, improvement in skin brightness, skin even tone and skin moisturization on healthy female subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-NF01-TI-NR21; Version: 01; Dated: 11/03/2022  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  Mr Satyendra Kumar 
Designation  Sr. Manager - Clinical Research 
Affiliation  Transformative Learning Solution Pvt. Ltd. 
Address  Transformative Learning Solution Pvt. Ltd. 3rd Floor, Veritas Tower, Sector 53, Gurugram, Haryana-122002

Gurgaon
HARYANA
122002
India 
Phone  9891253516  
Fax    
Email  satyendra.kumar@transformative.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  
Transformative Learning Solution Pvt Ltd, 3rd Floor, Veritas Tower, Sector 53,Gurugram, Haryana- 122002. 
 
Primary Sponsor  
Name  Transformative Learning Solution Pvt Ltd 
Address  3rd Floor, Veritas Tower, Sector 53,Gurugram, Haryana- 122002.  
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 
Suraksa- Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The subjects selected for this study are healthy females, aged between 35 and 55 years old, having crow’s feet wrinkles & fine lines on the face and having uneven skin tone.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kesaradi Oil (0221) : Product A  Product will be applied on the whole face, twice daily in morning and evening for the period of 28 days 
Comparator Agent  None  Not applicable 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1)Indian or 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)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
4) Having uneven skin tone
5) Having Crows feet wrinkle according to the Bazins atlas.  
 
ExclusionCriteria 
Details  1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months • Having refused to give her assent by signing the consent form
2 Taking part in another study liable to interfere with this study
3 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5 Having a progressive asthma (either under treatment or last fit in the last 2 years)
6 Being epileptic
7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8 Having cutaneous hypersensitivity
9 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
10 Having known allergy to any of the Ingredient of the Test Product.
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 interrupted one hormonal treatment (hormonal contraception, Hormone
17 Replacement Therapy) during the past 3 months
18 Having started, changed or stopped her tobacco consumption (for smokers consuming more than
19 10 cigarettes per day) in the previous 6 months
20 Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food
21 and/or not smoke in the two hours preceding the measurements
22 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn,
23 amiodarone, metals, minocycline…) in the previous 6 months
24 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroten)
25 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
26 Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid) in the 2 weeks preceding the start of the study.
27 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in
28 the 4 weeks preceding the start of the study.
29 Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice,
30 pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months
31 Having a suntanned skin on the studied areas which could interfere with the evaluations of the
32 Study
33 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   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in appearance of wrinkles & fine lines, improvement in skin brightness, skin even
tone and skin moisturization, product safety 
baseline, 8 hours after product application, 7 days, 14 days,28 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   24/05/2022 
Date of Study Completion (India) 13/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

The objective of this study will be to evaluate the efficacy and safety of a skin care formulation in terms of reduction in appearance of wrinkles & fine lines, improvement in skin brightness, skin even tone and skin moisturization on healthy female subjects

Product : Kesaradi Oil (0221) : Product A

The evaluation is performed using: Subject’s Self Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation: Efficacy, Chromametry (L* and ITA° parameter for skin brightness & Delta E parameter for skin even tone), Corneometry (Capacitance parameter Skin Moisturization), Illustrative Images of the whole face under diffuse light

Total duration of the study: 28 days following the first application of product.

Kinetics: T0, T+8 hours after product application, T+7 days, T+14 days and T+28 days 

Product application : Twice a day application on whole face for the period of 28 days

Number of volunteers: 33 + 3 female subjects

 

 
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