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CTRI Number  CTRI/2025/11/098010 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cosmetic]  
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate baby wash and moisturizing cream for atopic dermatitis in Indian children. 
Scientific Title of Study   A Multi-Center Clinical Evaluation of Efficacy of Baby Wash and Baby Moisturizing Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children in India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/JJAD/2025-01;CS2025SK100260 version 1 dated 24 Oct 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  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Divya Purusothaman 
Designation  Senior Scientist R&D Translational Science 
Affiliation  Kenvue 
Address  LBS Marg, West Mulund

Mumbai
MAHARASHTRA
400080
India 
Phone  9962695791  
Fax    
Email  PDivya01@kenvue.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr. Sudhanthiran 
Designation  Manager- techno-commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  8883338954  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
JNTL Consumer Health (India) Private Limited (Kenvue, India) LBS Marg, Mulund West, Mumbai 400080, India  
 
Primary Sponsor  
Name  JNTL Consumer Health (India) Private Limited (Kenvue, India) 
Address  LBS Marg, Mulund West, Mumbai 400080, India 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
none  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Ganjoo  Dr Ganjoos Skin and Laser Cosmetology Centre   105/4, LSC, Gujranwala Town
New Delhi
DELHI 		 9811066584

drganjoo1965@gmail.com 
DrRohit Batra  Dr Rohit Batra’s DermaWorld Skin and Hair Clinic  Q-4, Rajouri Garden,
New Delhi
DELHI 		 9911200050

drrohitbatra@gmail.com 
Dr Mukta Sachdev  MS Clinical Research Pvt. Ltd  327/15,1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 09952700028

mukta.sachdev@msclinical.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
GSER-IEC  Approved 
GSER-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Baby Moisturizing Cream (11336-165)  Frequency: twice daily on the entire face and body (avoiding the eye area). Duration: 8 weeks Quantity: Apply adequate amount focusing on lesion area and then for the entire body. Gently massaging cream onto skin to help soothe and moisturize the skin.  
Intervention  Baby Moisturizing Wash (14013-95)  Frequency: at least three times a week, but no more than once daily to maintain skin health without over-drying. Duration: 8 weeks Quantity: For infants: adequate amount of product will be rubbed in the palm to form lather and then applied on the body and face. For toddlers and children: the product can be used directly on the face and body.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  6.00 Year(s)
Gender  Both 
Details  For both Non-steroid and Steroid using group
1. Male/Female
2. Participants between the age of 3 months to 6 years.
3. Has mild to moderate atopic dermatitis with at least 1 target lesion based on the ADSI with a score from 2 to 8.5 and an erythema sub score of at least 2 (moderate).
4. Has parent-assessed history of itch, scoring from 2 to 4 in Caregivers Itch Assessment scale (CIA).
5. Has parent-perceived sensitive skin.
6. Generally, in good health based on medical history reported by the participant.

For Non steroid using group
7. Participant who reported to have atopic dermatitis for the first time can also be included
8. Participants with a treatment-free period for treatment: injectable corticosteroids: 60 days, systemic corticosteroids: 30 days, topical corticosteroids: 30 days, topical immunomodulators: 30 days, antihistaminic: 15 days

For Steroid using group
9. Participants who are currently using low potency topical steroids or participants who are required to start low potency topical steroids.
10. Must have experienced at least one episode of flare-up in the past 12 months where low potency topical steroids (Class IV to VII) were used.
11. Must have been on a stable dose of topical corticosteroids (Class IV to VII).
12. Patient with a treatment-free period for: injectable corticosteroids: 60 days, systemic corticosteroids: 30 days, topical immunomodulator: 30 days, antihistaminic: 15 days

Parent Only
1. 18-65 years of age
2. Literate (Able to read, write, speak English/ Kannada/Tamil/ Hindi)
3. Willing to replace the participant’s current body wash with the investigational wash and apply the investigational cream as instructed throughout the study.
4. Has a smart phone capable of receiving text messages and accessing the internet and agree to complete questionnaires via text message.
5. Intends to successfully complete the study and is willing and able to follow the participant responsibilities.
6. Prior to Baseline and during the study: willing to stop all emollients, moisturizers and/or other skin barrier cream or emulsion treatments for the Atopic dermatitis condition for the washout period and for the study duration; willing to stop all face and body wash products for washing the child during the study.
7. For medicated group: Must be aware of the child participant’s previous history of steroid treatment.
 
 
ExclusionCriteria 
Details  Child (includes infants, toddlers, and children) and Parent:
1. Patients with asthma/food allergy.
2. Presents with a health condition and/or pre-existing acute or chronic dermatologic conditions (e.g., psoriasis, rosacea, rashes, many and/or severe excoriations, etc.) that could interfere with the outcome of the study or be deemed inappropriate for study participation as determined by the PI.
3. Has known allergies or adverse reactions to common topical skincare products or ingredients of the IPs.
4. Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
5. Is taking medications that would mask an AE or influence the study results, for all participants and all parents including: Immunosuppressive drugs or steroidal (Class I, II, III) drugs within 2 weeks before Visit 1 and during the study; non-steroidal anti-inflammatory drugs within 5 days before Visit 1 and during the study; Antihistamines within 2 weeks before Visit 1 and during the study; Other prescription or OTC medications, that may interfere with study evaluations (use of acetaminophen and/or ibuprofen as needed is acceptable if it was instructed by the child’s pediatrician).

If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a participant begins using one of these medications during the study, the Study PI should be consulted to consider the impact of the specific medication on participant safety and/or the study results as described in Concurrent/Concomitant Medication.

6. Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual’s participation in the study.
7. Is an employee/contractor or household family member of the PI, Study Site, or Sponsor.
8. Is simultaneously participating in any other clinical study or has participated in another clinical study in the past 30 days.
Parent only:
9. Is self-reported to be pregnant or planning to become pregnant during the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of regimen (Wash: IP A + moisturizing cream: IP B) in infants/toddlers/children with mild to moderate atopic dermatitis for reduction in severity of atopic dermatitis by clinical assessment.  T0(baseline),Timm,T1(1 hour after application),T2 (Day 1),T3 (week 1),T4(week 3) and T5 (week 8) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of regimen (Wash: IP A + moisturizing cream: IP B) among infants/toddlers/children with Atopic dermatitis:
- in reducing itching associated with atopic dermatitis.
- in improving skin hydration.
- in improving skin barrier.
- in improving sleep quality.
- in enhancing the quality of life (QoL).
- in managing flare-ups.
 		 T0(baseline),Timm,T1(1 hour after application),T2 (Day 1),T3 (week 1),T4(week 3) & T5 (week 8) 
To evaluate safety & tolerance of regimen moisturizing cream & wash.  T0(baseline),Timm,T1(1 hour after application),T2 (Day 1),T3 (week 1),T4(week 3) & T5 (week 8) 
To determine the reduction in medication/steroid usage  T0(baseline),Timm,T1(1 hour after application),T2 (Day 1),T3 (week 1),T4(week 3) & T5 (week 8) 
To evaluate the improvement in the lipidomic profile   T0(baseline),Timm,T1(1 hour after application),T2 (Day 1),T3 (week 1),T4(week 3) & T5 (week 8) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   06/12/2025 
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="4" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Atopic dermatitis (AD) is a most common inflammatory skin condition of eczema that affects a significant number of infants, toddlers, and children in India. Characterized by dry, itchy, and inflamed skin, AD leads to discomfort, sleep disturbances, and a compromised quality of life for both affected children and their families.

 

The IPs in this study, a Baby Moisturizing Wash and a Baby Moisturizing Cream, contain a formulation enriched with triple oat, known for its hydrating and soothing properties. Previous studies have shown these products to be beneficial for sensitive and eczema-prone skin. However, there is a need for robust clinical data to substantiate their efficacy and safety specifically in the Indian pediatric population.

 

This clinical trial aims to evaluate the efficacy and safety of the Baby Moisturizing Wash and Baby Moisturizing Cream in infants, toddlers, and children diagnosed with atopic dermatitis across different geographical locations with distinct climatic condition in India. By conducting this study, we seek to provide critical evidence that will not only support the continued use of these products but also contribute to enhancing the overall management of atopic dermatitis in young children.

 
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