| CTRI Number |
CTRI/2018/07/015053 [Registered on: 26/07/2018] Trial Registered Prospectively |
| Last Modified On: |
12/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to compare clinical and causative factors of allergic contact dermatitis with the help of indian standard patch test series in a tertiary centre |
|
Scientific Title of Study
|
Clinico-etiological correlation of allergic contact dermatitis with indian standard patch test series in a tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somya Sharma |
| Designation |
postgraduate resident 1st year |
| Affiliation |
peoples college of medical science and research centre |
| Address |
Peoples College of medical science and research centre ,
bhanpur Bridge road
peoples campus ,bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9425432103 |
| Fax |
|
| Email |
somya2090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar Dey |
| Designation |
HOD & Professor Department Of Dermatology |
| Affiliation |
peoples college of medical science and research centre |
| Address |
OPD NO 8
Peoples Hospital
Peoples College of medical science and research centre ,
bhanpur Bridge road
peoples campus ,bhopal
peoples hospital ,
bhanpur bridge road
bhopal (M.P.)
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9981346039 |
| Fax |
|
| Email |
drvivekdey@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somya Sharma |
| Designation |
postgraduate resident 1st year |
| Affiliation |
peoples college of medical science and research centre |
| Address |
Peoples College of medical science and research centre ,
bhanpur Bridge road
peoples campus ,bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9425432103 |
| Fax |
|
| Email |
somya2090@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Somya sharma |
| Address |
peoples college of medical science and research centre , bhanpur bridge road , peoples campur , bhopal |
| Type of Sponsor |
Other [self] |
|
|
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 somya sharma |
peoples college of medical science |
OPD No - 8
Department of Dermatology
Bhopal
MADHYA PRADESH |
9425432103
somya2090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Allergic Contact Dermatitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who gave consent for patch testing.
2.All cases of allergic contact dermatitis .
3.Age group between 20 and 70 years.
4. Both sex
|
|
| ExclusionCriteria |
| Details |
1. Age groups less than 20 years and more than 70 years.
2. Pregnant Females
3. Primary irritant dermatitis
4. Other endogenous eczemas
5. Patients presenting with active, flaring dermatitis.
6.Patients on any systemic corticosteroids, immunosuppressant, PUVA therapy for atleast 2 weeks prior to patch test.
7. If topical steroids are being used on the back, patch testing should be delayed for 3 days.
8. Photo allergic contact dermatitis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Causes of allergic contact dermatitis |
1.8 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| causes of allergic contact dermatitis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study is recruiting participants |