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CTRI Number  CTRI/2026/01/100064 [Registered on: 01/01/2026] Trial Registered Prospectively
Last Modified On: 31/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [lotion with vitamin C and E ]  
Study Design  Single Arm Study 
Public Title of Study   A study to see whether a new medicated calamine lotion reduces itching and skin discomfort in children with dermatitis 
Scientific Title of Study   Development and validation of calamine lotion infused with vitamin C, vitamin E and chlorpheniramine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shruthi 
Designation  Postgraduate 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1 st floor, department of paediatrics, Saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu

Chennai
TAMIL NADU
602105
India 
Phone  9840924397  
Fax    
Email  shruthijayasankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navin 
Designation  assisstant professor 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1 st floor, department of paediatrics, Saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu

Chennai
TAMIL NADU
602105
India 
Phone  9487002379  
Fax    
Email  navinu.smc@saveetha.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navin 
Designation  assisstant professor 
Affiliation  Saveetha medical college hospital 
Address  ward number 120, 1 st floor, department of paediatrics, Saveetha medical college hospital,162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu


TAMIL NADU
602105
India 
Phone  9487002379  
Fax    
Email  navinu.smc@saveetha.com  
 
Source of Monetary or Material Support  
Saveetha medical college hospital 
 
Primary Sponsor  
Name  Saveetha medical college hospital 
Address  162, Poonamallee High Road, Poonamallee, Chennai, Kuthambakkam, Tamil Nadu 602105 
Type of Sponsor  Private medical college 
 
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 Shruthi  Saveetha medical college hospital  ward number 120, 1st floor, department of paediatrics,162, Poonamallee High Road, Poonamallee, Chennai,
Chennai
TAMIL NADU 
9840924397

shruthijayasankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L30||Other and unspecified dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Topical application of calamine lotion infused with vitamin C, vitamin E and chlorpheniramine, applied as per protocol.  calamine lotion is applied in children with dermatitis for a period of 2 weeks. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 2-12 years diagnosed clinically with dermatitis like allergic dermatitis, psoriasis or lichen planus whose caregivers provide written informed consent. 
 
ExclusionCriteria 
Details  Children with infected skin lesions, known hypersensitivity to study components, severe systemic illness, or those on concurrent systemic immunosuppressive therapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pruritus severity assessed using a validated itch score at the end of 4 weeks.  Reduction in pruritus severity assessed using a validated itch score at the end of 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in sleep quality
Caregiver satisfaction
Treatment adherence
Safety and tolerability of the formulation 
baseline, 2 weeks, 4 weeks 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/01/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 study is a pilot interventional trial designed to develop and validate a novel topical calamine lotion formulation infused with vitamin C, vitamin E and chlorpheniramine for the management of dermatitis in children. Dermatitis is a common paediatric dermatological condition associated with significant pruritus, sleep disturbance and caregiver burden, often requiring safe and effective topical therapies suitable for long-term use.The study will be conducted at the Department of Paediatrics, Saveetha Medical College and Hospital, Chennai, after obtaining Institutional Ethics Committee approval. Children aged 2-12 years diagnosed clinically with dermatitis, including allergic dermatitis, psoriasis and lichen planus, will be recruited after obtaining informed consent from parents or legal guardians.Following a baseline observation period of two weeks, eligible participants will receive topical application of the study formulation for a duration of four weeks. Participants will be monitored at predefined intervals for clinical response and safety. The primary outcome of the study is reduction in pruritus severity, assessed using a validated itch scoring system. Secondary outcomes include improvement in sleep quality, caregiver satisfaction, treatment adherence and tolerability of the formulation.This pilot study aims to generate preliminary evidence regarding the efficacy, safety and acceptability of the fortified calamine lotion in paediatric dermatitis. The findings are expected to inform the feasibility and design of larger randomized controlled trials and contribute to the development of affordable, child-friendly topical treatment options for inflammatory skin disorders.

 
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