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CTRI Number  CTRI/2024/07/069981 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Clinical characterization and patch testing in pediatric hand foot dermatitis 
Scientific Title of Study   Clinical characterization and patch testing in pediatric hand foot dermatitis an observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shatabdee Sahoo 
Designation  PG 2nd year resident 
Affiliation  IMS and SUM hospital 
Address  Department of skin and VD, IMS and SUM Hospital, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha

Khordha
ORISSA
751003
India 
Phone  9178292407  
Fax    
Email  shatabdeesssahoo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Maitreyee Panda 
Designation  professor 
Affiliation  IMS and SUM hospital 
Address  Department of skin and VD, IMS and SUM Hospital, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha

Khordha
ORISSA
751003
India 
Phone  9437218952  
Fax    
Email  pandamaitreyee@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shatabdee Sahoo 
Designation  PG 2nd year resident 
Affiliation  IMS and SUM hospital 
Address  department of Skin and VD, IMS and SUM Hospital, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha

Khordha
ORISSA
751003
India 
Phone  9178292407  
Fax    
Email  shatabdeesssahoo@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM hospitaL, Shampur, bhubaneswar, Odisha- 751003 
 
Primary Sponsor  
Name  IMS and SUM hospital 
Address  IMS and SUM hospital, Sum Hospital Rd, Shampur, Bhubaneswar, Odisha 751003 
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 Shatabdee Sahoo  Instititute of Medical sciences(IMS) and SUM hospital  Department of Dermatology Venereology and Leprosy(DVL), IMS and SUM Hospital, Shampur, Bhubaneswar
Khordha
ORISSA 
9178292407

shatabdeesssahoo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, IMS and SUM Hospital, SOA University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  patch test in hand foot dermatitis patients  Patch testing to be done with Indian standard battery(20 allergens) put over upper back of patient. The Indian standard battery(ISB) comes with a series of 20 prefilled syringes of allergens. 2-5mm length of allergen(test substance) is taken on each Finn chamber and carefully put over non hairy part of upper back of patient. It is secured with adhesive tape. Patient is followed up after 48 hours for test results/ interpretation. Patient is followed up after 72 hours, 96 hours and after 7 days if any late reactions are suspected. Results are noted according to Internatinoal contact dermatitis research group(ICDRG) scoring guidelines. Patch testing is only done once and not repeated further, even if results come negetive. 
Comparator Agent  patch test with petrolatum only  Comparator agent used is patch test with only petrolatum jelly put over upper back of same patient. Petrolatum is inert, so does not cause contact allergy. 2-5 mm length of jelly is put in Finn chamber and used in patch test along side the regular Indian standard battery allergens. Patient is followed up on same days i.e, 48 hours, 72 hours, 96 hours and 7 days. All patches are removed after 48 hours and compared for any contact allergy according to guidelines. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  clinical, dermoscopic and biopsy proven hand foot dermatitis of chronic recurrent course 
 
ExclusionCriteria 
Details  1. History of congenital skin disorder
2. History of immunocompromised disorders
3. History of auto immune diseases
4. History of drug rashes
5. History of Type 1 diabetes mellitus, hypothyroidism and other endocrine abnormalities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
% of different types of hand foot eczema  day 1 
 
Secondary Outcome  
Outcome  TimePoints 
patch test interpretation  48 hours, 72 hours, 96 hours and after 7 days 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   24/07/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shatabdeesssahoo@gmail.com].

  6. For how long will this data be available start date provided 25-03-2026 and end date provided 25-03-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Hand foot dermatitis that includes atopic dermatitis and contact dermatitis, is common in children. Dermatitis presenting with atypical distribution or dermatitis that is recalcitrant or worsening despite topical treatment should raise clinical suspicion for ACD and referral for patch testing is recommended.

A good clinical evaluation of allergic contact dermatitis involves a detailed history and physical examination. The morphology and location of the dermatitis is often the best indicator of the offending agent.

Epidemiology- Among children with suspected contact dermatitis referred for patch testing, positive patch test rates have ranged from 14% to 70%. In contrast, there are some population-based patch test studies of unselected pediatric patients (sample size 85–1,146 patients per study), where positive patch test rates ranged from 13% to 24%, significantly lower than the rates seen in patients selected for suspected contact dermatitis. The largest of these studies, which also provides specific relevance information, found the prevalence of past or current relevant reactions to be 7%, with a higher risk seen in females.

Pathophysiology- Allergic contact dermatitis starts with the contact of the allergen to the skin. ACD is a delayed-type IV hypersensitivity reaction that occurs with cutaneous exposure to allergens. This allergen penetrates that stratum corneum of the skin and is taken up by Langerhans cells. In the sensitization phase, the allergen is captured by antigen-presenting cells and subsequently migrate to the draining lymph nodes. This results in the activation of naive T cells, which differentiates into allergen-specific memory T cells. Upon re-exposure to the allergen, these memory T cells become activated and migrate to the site of exposure, leading to manifestation of ACD. The exact pathogenesis of ACD is unknown though cytotoxic T, T helper (h) 1, Th2, Th17, and Th22 cells have all been implicated in the development of ACD. 

ACD and atopic dermatitis can coexist and certain clinical features can help differentiate ACD from endogenous atopic dermatitis in children. It is important to consider ACD in children with recalcitrant atopic dermatitis or dermatitis with atypical distribution

Patch tests should be supported because confirmatory value of patch tests enables physicians to proceed with confidence

children with atopic dermatitis are more vulnerable to contact sensitization due to loss of normal barrier funtion of skin.

 
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