| CTRI Number |
CTRI/2024/09/073308 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Allergy testing in lips and eyelid allergy |
|
Scientific Title of Study
|
Role of Patch testing in Lip and Eyelid Dermatitis |
| 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 Aravind Suprakasan |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology,
Kasturba Medical College,
Manipal, Udupi,
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8943985007 |
| Fax |
|
| Email |
aravind.s@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aravind Suprakasan |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology,
Kasturba Medical College,
Manipal, Udupi,
Karnataka 576104
KARNATAKA
576104
India |
| Phone |
8943985007 |
| Fax |
|
| Email |
aravind.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjana Gopinathan M P |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology,
Kasturba Medical College,
Manipal, Udupi,
Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8075181976 |
| Fax |
|
| Email |
niranjana.kmcmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| IADVL Karavali Charitable Trust, Mangalore |
|
|
Primary Sponsor
|
| Name |
Dr Aravind Suprakasan |
| Address |
Department of Dermatology,
Kasturba Medical College,
Manipal, Udupi,
Karnataka 576104 |
| 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 Aravind Suprakasan |
Kasturba Medical College |
Room 21,
Department of Dermatology
Udupi
KARNATAKA |
8943985007
aravind.s@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 years of age and less than 60years
2. Patients attending dermatology OP with lip and eye lid dermatitis.
3. Patients consenting for patch test. |
|
| ExclusionCriteria |
| Details |
1. Patients on any immunosuppressive treatment (eg : oral corticosteroids, azathioprine, cyclosporine, tofacitinib)
2. Patients having extensive active dermatitis, exfoliative dermatitis
3. Pregnant patients
4. Patients having lesions on the back which will interfere with the application of patch or reading
5. Patients who are unable to come for 48 hour and 72-hour reading |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Itching or Faint erythema or papules or pustules or vesicles at the site of patch test |
first reading at 48 hours after application of patch and second reading at 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Itching or Faint erythema or papules or pustules or vesicles at the site of patch test |
Patch test site positive reaction occurring after 72 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/09/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Patients above the age of 18years with symptoms
of Lip and eyelid dermatitis will be included in the study. A total of 3 visits
to the hospital has to be done for Patch testing. Patch testing will be done
using ISS (Indian Standard Series) and Cosmetic Series. On the first visit, a
detailed history is taken with regard to the possible allergen exposures,
occupation, cosmetic use. A total of 55 patches (20+32) will be kept on the
posterior trunk and upper arms (if required) using standard aluminium chambers.
Second visit is on the Day 3 (48 hours), when patches will be removed and
reading will be done as per the ICDRG guideline. Third visit will be on Day 4
(72 hours) when second reading will be done. In case of excessive itching or
discomfort, patch will be removed prior to 48 hours and patient will be
withdrawn from the study.
|