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CTRI Number  CTRI/2026/03/105398 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 26/08/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study on Skin Barrier Health in Dry, Atopic-Prone Skin Compared to Normal Skin 
Scientific Title of Study   A Profiling Study to Evaluate Ceramide Levels, Skin Barrier Resiliency and associated biological markers in Atopic prone dry skin vs Normal Skin Under Indian Environmental Conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/LRPS/2025-21 Version: 1.0 Dated: 20 Feb 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Radhakrishna 
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  08040917253  
Fax    
Email  aishwarya.r@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director - Business and Operation 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
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  327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
L’Oreal India Pvt Ltd 7th Floor, Universal Majestic building, Ghatkopar Mankhurd Link Road Chembur east, Mumbai 400071  
 
Primary Sponsor  
Name  L’Oreal India Pvt Ltd 
Address  7th Floor, Universal Majestic building, Ghatkopar Mankhurd Link Road Chembur east, Mumbai 400071  
Type of Sponsor  Other [FMCG (Fast Moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Ganjoo  Dr Ganjoos Skin and Cosmetology Centre  105/4, LSC, Gujranwala Town Delhi - 110009
New Delhi
DELHI 		 9811066584

drganjoo1965@gmail.com 
Dr Aishwarya Radhakrishna  MS Clinical Research Pvt. Ltd  Department of Skin Sciences, #324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore, Karnataka, India
Bangalore
KARNATAKA 		 08040917253

aishwarya.r@msclinical.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
GSER-IEC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Trial participants with Normal skin and Atopic prone dry skin.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Female trial participants in general good health determined from a recent medical health history.
2) Trial participants of age group 18-45 years (both age inclusive).
3) Trial participants must meet one (and only one) of the following skin-type
specifications (normal skin and atopic dry skin in 1:1 ratio):
a. Participants with normal skin.
b. Participants with atopic dry prone skin.
4) Trial participants with Fitzpatrick skin type of III, IV and V.
5) Trial participants willing to give a voluntary written informed consent
6) Trial participants willing to abide by and comply with the study protocol. 
 
ExclusionCriteria 
Details  1) Trial participants with signs of significant local irritation or active dermatological conditions (eg., psoriasis, or skin infection).
2) Trial participants taking any medication which the Investigator believes may influence the interpretation of the data.
3) Trial participants having chronic illness or who have undergone major surgery in the last year.
4) Trial participants undergoing treatment for any skin condition.
5) Trial participants who are pregnant or nursing (self- declared).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Difference in skin barrier function and skin hydration between Normal and Atopic prone dry skin assessed by instrumental and clinical scoring.
2. Differences in tape strip–derived biomarker levels and lipid profile characterization between normal skin and atopic-prone dry skin groups.
 		 Day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Differences in skin barrier related outcomes and biomarker profiles between
study sites.  		 Day 1 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/03/2026 
Date of Study Completion (India) 19/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/05/2026 
Estimated Duration of Trial   Years="0"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 observational study aims to compare skin barrier characteristics and related biological indicators in females with atopic-prone dry skin and normal skin. Conducted at two centres in India, the study will use clinical evaluation, non-invasive instrumental measurements, and minimally invasive sampling to assess differences between groups.

 
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