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CTRI Number  CTRI/2023/09/057722 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 12/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Skin care formulation]  
Study Design  Single Arm Study 
Public Title of Study   Assessment of safety & Efficacy of skin care product 
Scientific Title of Study   The objective of this study will be to evaluate safety and efficacy of skin care formulation in terms of visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness on healthy female subjects. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
XXX-RF04-TI-DR22; Version: 01; Dated: 17/08/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raji Patil  
Designation  Principal 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
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

Gurgaon
HARYANA
122002
India 
Phone  9891253516  
Fax    
Email  satyendra.kumar@transformative.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
MAHARASHTRA
400013
India 
Phone  02243349191  
Fax    
Email  mohit.CTRI@gmail.com  
 
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 400013
Mumbai
MAHARASHTRA 		 02243349191

raji@mascotspincontrol.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha-Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  female subjects having crows feet wrinkles & fine lines of grade 2-4 and Pigmentary dark spot & loose skin (face, neck & inner upper arms). 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Not applicable 
Intervention  TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER-100 ML  3-5 drops as per moisturization needs. Massage into the face until absorbed. Take similar amount of oil and apply on the neck and décolleté. Massage until absorbed. For the body- Take enough oil to cover the part and massage gently till it gets fully absorbed. Apply the test product after a bath once a day for a period of 60 days.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 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.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar)
4.Having crows feet wrinkles, fine lines of grade 2-4 & Pigmentary dark spots.
5.Having loose skin(face, neck and upper arms).
 
 
ExclusionCriteria 
Details  1. Female subjects who are 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 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.
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 consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
13. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
14. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
15. Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted)
16. 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 consume any caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, -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 or skin care products other 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 test site cleaned with water is accepted)
17. Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.
18. Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
19. Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
20. 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.
21. Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months.
22. Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year.
23. Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
24. Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
25. Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
26. 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.
27. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study.
28.Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week.
29.Having practiced sport, the day of start of the study.
30. 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 use products or techniques or surgery with an anti-wrinkles/ anti ageing action /firming action and depigmenting/ whitening action, - 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 practice water activities (swimming pool, sauna, hammam, balneotherapy.), - Do not practice sport the days of study, - Do not expose herself 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 
Visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness  Baseline, Immediate after application, 15 days, 28 days, 45 days & 60 days  
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in circumference of inner upper arm  Baseline, Immediate after application, 15 days, 28 days, 45 days & 60 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)   20/09/2023 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 PRIMARY OBJECTIVE: The objective of this study will be to evaluate safety and efficacy of skin care formulation in terms visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness on healthy female subjects.

SECONDARY OBJECTIVE: Secondary objective is to evaluate the safety & efficacy of a skin care formulation in terms of reduction in circumference of inner upper arm.

 

TestpProduct : TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER-100 ML

 

The evaluation is performed using: Subject’s Self Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation: Efficacy, Measurement of circumference of inner upper arms, Chromametry (L* parameter for skin brightness & DE parameter for skin even tone) , Cutometry (R0 parameter for skin firmness) , Corneometry (Capacitance parameter Skin Moisturization) 

 

Total duration of the study: 60 days following the first application of product. 

 

Kinetics: T0, T immediate after product application, T+15 days after Product application, T+28 days after Product application, T+45 days Product application & T+60 days after Product application

 

Number of volunteers: 36 female subjects will be selected for the study. 

aged between 35 and 55. years old,having crow’s feet wrinkles & fine lines of grade 2-4 and Pigmentary dark spot & loose skin (face, neck & inner upper arms).


 
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