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CTRI Number  CTRI/2025/06/089217 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   Study to test the safety and effectiveness of test product to provide various skin benefits in participants over 56 days of test product usage 
Scientific Title of Study   A Clinical Study to Evaluate the Safety and Efficacy of the Test Product in Providing Various Skin Benefits. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/PUSS/2025-01 version 1.0 dated 03 June 2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukta Sachdev 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  918040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director business and operation  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax    
Email  ritambhara@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Manager - Techno-commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  8040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Antonio Puig S.A 
 
Primary Sponsor  
Name  Antonio Puig S.A 
Address  Plaza Europa 46-48 LHospitalet de Llobregat Barcelona 08902 Cataluria Spain 
Type of Sponsor  Other [Other [Cosmetics]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukta Sachdev  MS Clinical Research Pvt. Ltd  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 918040917253

mukta.sachdev@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI VENKATESHWARA HOSPITAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female subjects in general good health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Serum UV drops  Apply at least two pumps of product and blend evenly over your face, neck and neckline in the morning. Use as the last step of your skincare routine, after your moisturizing cream or lotion and then proceed to apply your make up. Use 15 minutes before sun exposure. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Female subjects in general good health.
2. Female subjects in the age group 20 to 65 years.
3. Female subjects with all skin types, with 50% of subjects having sensitive skin.
4. Female subjects with visible skin concerns such as dark spots, wrinkles, and uneven skin tone.
5.10 female subjects with sensitive eyes who regularly wear contact lenses.
6.Female subjects who are regular users of makeup. 
 
ExclusionCriteria 
Details  1. Subjects with known skin conditions that may impact the assessment.
2. Subjects with any other signs of significant local irritation or skin disease.
3. Subjects undergoing treatment of any skin condition on their face.
4. Subject having active skin diseases.
5. Subjects who have undergone facial treatments in past 4 weeks. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of efficacy of test product in reducing signs of ageing.
Assessment of the test products effectiveness in improving overall skin tone.
Evaluation of efficacy of the test product for reduction in dark spots.
Reduction in signs of ageing using Antera assessment.
Reduction in dark spot intensity using Spectrophotometer.
Evaluation of improvement in skin elasticity using Cutometer. 		 Baseline, Day 28, Day 56. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluation of Safety and tolerability of the test product through dermatological and ophthalmological assessments.
2. Assessment of prevention of dark spots through subject self assessment. 		 Baseline, Day 28, Day 56. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/06/2025 
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)   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  

This is a study to evaluate the safety and efficacy of a test product to provide various skin benefits utilizing a full-face single arm study design. Duration of testing [length of time]: 56 days. The study will include a variety of dermatological assessments, instrumental assessments, and self assessments from subjects. Study objectives: improvements in signs of the aging face, overall skin tone, dark spot reduction, skin elasticity and testing of the safety and tolerability of the test product.

 
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