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CTRI Number  CTRI/2026/03/105667 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety and Tolerability Study]  
Study Design  Single Arm Study 
Public Title of Study   Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of TediBar Ceramax Head to toe Bodywash in Infants and Toddler up to 2 Years of age. 
Scientific Title of Study   A Clinical Study to Evaluate the Safety and Tolerability of Tedibar Ceramax Head to Toe Bodywash in Paediatric Population.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/TPPS/2026-01 Version: 1.0 Dated: 18 Feb 2026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharil P Hedge 
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  sharilhegde@yahoo.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  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  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  
Torrent Pharmaceuticals Ltd. Research Centre, Village Bhat – 382428 Dist. Gandhinagar Gujarat  
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Ltd. Research Centre 
Address  Village Bhat – 382428 Dist. Gandhinagar Gujarat  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sharil P hedge  MS Clinical Research Pvt. Ltd  327/15,1st Main Road, Cambridge Layout,Ulsoor,
Bangalore
KARNATAKA 		 08040917253

sharilhegde@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infant and toddler up to 2 years of age in general good health as determined from a recent general examination by a pediatrician and dermatologist. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Tedibar Ceramax Head to Toe Bodywash   The product is a topical cosmetic body wash that will be applied during bathing using a small quantity on wet skin and scalp, gently lathered from head to toe, and thoroughly rinsed. It will be used at least once daily for 28 days. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  24.00 Month(s)
Gender  Both 
Details  1. Male and female trial participant in the age group, day 1 to 24 months of age on the day of enrolment.
2. Trial participant in general good health as determined by a paediatrician or dermatologist (as applicable) by a recent medical history.
3. Trial participant’s (parent or LAR) willing to give a voluntary written informed consent and agree to come for follow up.
4. Trial participant’s (parent or LAR) agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.
5. Trial participant’s (parent or LAR) willing to abide by and comply with the study protocol requirement for his/her child. 
 
ExclusionCriteria 
Details  1. A known history or present condition or any other concern that may require medical attention.
2. Trial participant deemed unfit to participate in the study based on the general health and hygiene
3. Trial participant having active skin diseases which will interfere with the test results.
4. Trial participant who has mild to moderate signs of local irritations like erythema, dryness, scaling/peeling, urticaria, acneiform eruptions, allergic reaction will be considered but severe signs will be avoided. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Safety and tolerability of the test product assessed by dermatological evaluation and paediatrician’s assessment.
2. Improvement of skin hydration achieved based on Corneometer measurements  		 Baseline, 30 minutes after first application, Day 14, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Safety, tolerability, efficacy perception, and product acceptability achieved based on parent/caregiver feedback questionnaire responses   Baseline, 30 minutes after first application, Day 14, Day 28 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/03/2026 
Date of Study Completion (India) 04/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/06/2026 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   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  

Participants will be screened according to the inclusion and exclusion criteria, and eligible participants will be enrolled after obtaining written parental consent.

The test product will be provided to parents/caregivers with instructions to use it during the child’s regular bathing routine at least once daily for 28 days.

Dermatological assessments, paediatrician’s evaluations, instrumental measurements of skin hydration, and parent/caregiver feedback will be conducted at Baseline, 30 minutes after the first application (Timm), Day 14 (Week 2), and Day 28 (Week 4).

 
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