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CTRI Number  CTRI/2023/05/052885 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 22/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cosmetics]  
Study Design  Other 
Public Title of Study   A study to evaluate skin moisturization. 
Scientific Title of Study   A randomized, double-blinded, controlled study to evaluate the efficacy of test products in providing skin moisturization and barrier protection for up to 24 hours in healthy subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/SLHS/2023-02 version 1.0 Dated 11th April  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator  
Affiliation  MS Clinical Research Pvt Ltd 
Address  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax    
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Ltd 19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  9900128263  
Fax    
Email  satish.g@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group Ltd 
Address  Sami-Sabinsa Group Ltd 19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore

Bangalore
KARNATAKA
560058
India 
Phone  9900128263  
Fax    
Email  satish.g@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Ltd 19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore – 560058 
 
Primary Sponsor  
Name  Sami-Sabinsa Group Ltd  
Address  19/1, 19/2, I Main, II Phase Peenya Industrial Area Bangalore – 560058 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
none  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukesh Ramnane  MS Clinical Research Pvt Ltd  Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA 		 08041125934

mukesh.ramnane@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CLINICOM Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy female Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Tvaksh Moisguard DN  An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syringe and carefully spread with a finger protected with a finger cot. Then the product has to be allowed to be absorbed for at least 5 minutes on the uncovered area of the inner forearm 
Intervention  2.Tvaksh Moisguard Ex  An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syringe and carefully spread with a finger protected with a finger cot. Then the product has to be allowed to be absorbed for at least 5 minutes on the uncovered area of the inner forearm 
Intervention  3. Tvaksh Moisguard Sensi  An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syringe and carefully spread with a finger protected with a finger cot. Then the product has to be allowed to be absorbed for at least 5 minutes on the uncovered area of the inner forearm 
Intervention  4. Tvaksh Moisguard BTR  An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syringe and carefully spread with a finger protected with a finger cot. Then the product has to be allowed to be absorbed for at least 5 minutes on the uncovered area of the inner forearm 
Intervention  5.Tvaksh Moisguard AC  An amount of 2 mg (µl) per cm2 has to be applied on each randomized test site. The product has to be dispensed from a positive displacement pipette/ disposable syringe and carefully spread with a finger protected with a finger cot. Then the product has to be allowed to be absorbed for at least 5 minutes on the uncovered area of the inner forearm 
Comparator Agent  untreated control  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Healthy female subjects, as determined from a recent medical history.
2. Subjects in the age group of 18-45 years (both ages inclusive).
3. Subjects who present normal to dry skin on the forearm (corneometer value of
35 as maximum)
4. Healthy skin in the test sites.
5. Subjects willing to give voluntary written informed consent and agree to come
for regular follow-up.
6. Subjects willing to abide by and comply with the study protocol.
7. Subjects who are willing not to participate in any other clinical study during participation in the current study.
 
 
ExclusionCriteria 
Details  1. Excessive hair on the test site
2. A known history or present condition of an allergic response to any cosmetic
products.
3. Change personal nutrition habits as well as sports habits
4. Start or change their oral hormonal treatment or their oral contraception.
5. Subject having active skin diseases (e.g., active atopic dermatitis, pigmented
contact dermatitis or other cutaneous manifestations), which will interfere with
the assessment.
6. Subjects on oral medications (e.g. steroids, anti-oxidant) which will
compromise the study.
7. Subjects had cancer in the last 10 years
8. Subjects with wounds, sunburn, scars, tattoos or piercings at the skin test
site(s)
9. Subjects with application of ointments, creams etc. for antibacterial, antiallergic or immunosuppressive treatment of the skin at the test site(s)
10.Systemic treatment which may modify the cutaneous state on the day of
inclusion or in the previous 30 days, including retinoid therapy.
11. History of intense sun exposure and/ photo toxicity/allergy.
12.Female subjects who are pregnant, lactating or nursing.
13.Chronic illness which may influence the cutaneous state.
14.Subject participating in any other cosmetic or therapeutic trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare skin moisturization using Corneometer – CM 825 with a single application of the test product in comparison to the baseline and untreated control.
2. To evaluate the retention of skin moisturization for immediate, 4 hours, 8 hours, and 24 hours using Corneometer – CM 825 with a single application of the test product in comparison to the untreated site.
3. To evaluate the deep moisturization: TEWL with a single application of the test product in comparison to the untreated site.
4. To measure and compare TEWL at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product in comparison to the baseline and untreated control.  		 Baseline, Immediate, 4 hours, 8 hours and 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy based on the dermatological visual assessment at immediate, 4 hours, 8 hours, and 24 hours with a single application of the test product compared to the baseline and untreated control.  Baseline, Immediate, 4 hours, 8 hours and 24 hours 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/05/2023 
Date of Study Completion (India) 01/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
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 study is designed to evaluate the moisturization benefits of multiple products and maintenance of efficacy for 24 hours in comparison to the baseline and the untreated site/ control site/s by an investigator-blinded, permuted, randomized, comparative and controlled study.

35 healthy female subjects after satisfying the inclusion exclusion criteria will be enrolled of which 30 subjects is required to complete the study. Post enrolment, the participants will undergo a Washout period for 5±2 days. After wash-out participants will be asked to report for the assessment visit in the morning and asked to wash their forearms with water and tap dry with paper towels. The products and control will be allotted as per randomization. After completion of baseline measurements, study personnel will apply the test products to the test product sites as per the randomization and assessment will be done at different time intervals.

 
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