| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shatabdeesssahoo@gmail.com].
- 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.
- 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. |