| CTRI Number |
CTRI/2022/12/048089 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
07/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of keloid |
|
Scientific Title of Study
|
Assessment of therapeutic outcomes among patients with keloid using Patient Observer Scar Assessment Scale (POSAS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Bhesaniya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105078072 |
| Fax |
|
| Email |
priya.bhesaniya95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Rao |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845292640 |
| Fax |
|
| Email |
jenny.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priya Bhesaniya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Dermatology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105078072 |
| Fax |
|
| Email |
priya.bhesaniya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka
Pin- 576104 |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [] |
|
|
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 Priya Bhesaniya |
Kasturba Hospital |
Room no. 21, Department of Dermatology, Udupi - Hebri Rd, Madhav Nagar, Manipal
Udupi
KARNATAKA |
8105078072
priya.bhesaniya95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L918||Other hypertrophic disorders of the skin, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing treatment for keloid |
|
| ExclusionCriteria |
| Details |
Those patients who do not give consent for their lesion to be photographed and those who are not willing to take the POSAS questionnaire |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the etiology and clinical profile of patients with keloid |
30/09/24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the patient satisfaction with respect to the different treatment modalities using the POSAS questionnaire |
30/09/24 |
| To study the dermoscopic features of keloid |
30/09/24 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
14/12/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Consent will be taken from the patient after explaining the study to the patient. Using a standard proforma, details regarding history, clinical examination and dermoscopic findings will be recorded. The POSAS questionnaire will be administered. Photograph of the lesion will be taken. The treatment for the keloid will be advised by the treating dermatologist and will be given by the respective doctor. Patient will be followed up after 4-8 weeks for 4 sessions and on each visit the clinical examination, dermoscopy of the lesion will be done and the questionnaire will be administered. There will be no extra cost to the patient |