| 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
|
|
|
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
|
|
|
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. |