| CTRI Number |
CTRI/2024/11/076621 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy and Safety of film forming spray in a patient with plaque psoriasis |
|
Scientific Title of Study
|
Clinical Evaluation of Film forming spray (FFS)in Patients with Plaque Psoriasis A Prospective Open labelled Split Body Comparative 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 |
Bikash Ranjan Kar |
| Designation |
Professor and HOD Department of Dermatology,Venereology and Leprosy |
| Affiliation |
Institute of medical science and sum Hospital |
| Address |
Professor and Head of department Department of Dermatology,Venereology and Leprosy Institute of medical science and sum Hospital K8 KALINGANAGAR ,GHATIKIA,KHORDHA 751003
Khordha
ORISSA
751003
India |
| Phone |
7978286893 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
Professor and Head of department Dermatology,Venereology and Leprosy |
| Affiliation |
Institute of medical science and sum Hospital |
| Address |
Professor and Head of DepartmentDermatology,Venereology and Leprosy
Institute of medical science and sum Hospital K8 KALINGANAGAR ,GHATIKIA,KHORDHA 751003
Khordha
ORISSA
751003
India |
| Phone |
7978286893 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bikash Ranjan Kar |
| Designation |
Professor and Head of Department Dermatology,Venereology and Leprosy |
| Affiliation |
Institute of Medical Science and Sum HOSPITAL |
| Address |
Professor and Head of department Dept of Dermatology,Venereology and Leprosy
Institute of Medical Science and Sum HOSPITAL K8 KALINGANAGAR ,GHATIKIA,KHORDHA 751003
Khordha
ORISSA
751003
India |
| Phone |
7978286893 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute Of Medical Science and Sum Hospital KHORDHA ,751003 |
|
|
Primary Sponsor
|
| Name |
Siksha o anusandhan university |
| Address |
Department of dermatology,venereology and leprosy Institute of Medical Science And Sum Hospital K8 kalinganagar ghatikia khordha 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 Tanisha Nayak |
Institute of Medical Science and Sum HOSPITAL |
Department of dermatology Ims and sum hospital K8 kalinganagar ghatikia khordha 751003
Khordha
ORISSA |
7978286893
tanisha.nayak1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Institute of medical sciences and sum hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L40||Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clobetasol oinment |
This is a split body comparative study at one side patient is asked to apply clobetasol ointment with film forming spray and at other side patient asked to apply only clobetasol ointment for total of 4 weeks |
| Intervention |
clobetasol ointment with film forming spray |
this is a split body comparative study at one side patient asked to apply clobetasol ointment with film forming spray and at other side patient is asked to apply only clobetasol ointment for total 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
outpatients aged ≥18 years with mild to moderate chronic stable plaque psoriasis affecting ≤10% BSA
Patients having at least 2 symmetrical psoriatic lesions that are similar in erythema, induration, and scaling.
Target lesions (plaques) diameter ≤5 cm
Target lesions (plaques) must have had a total modified HD PASI score of 4 or greater and are within 1 point of each other for each of the 3 parameters (erythema, induration, and scaling)
Willing to comply with study procedures, treatments (topical steroid ointment application) and assessments
|
|
| ExclusionCriteria |
| Details |
Lesion localized to scalp, face, groin area
Use of biological therapies/systemic anti-psoriatic treatment (previous 12 weeks).
Patients with evidence of a skin disorder other than plaque-type psoriasis, clinically infected psoriasis, and/or skin atrophy in the area of the target lesion.
Hypersensitivity to alcohol-based preparation
Pregnancy , Lactation
Severe renal impairment or severe hepatic disorders
Use of topical Anti-psoriatic in last 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the end of 4 weeks.
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the Change from baseline in the overall severity score (OSS) of psoriatic plaques at the week 1 and week 2.
To assess Change from baseline in the scores for Modified HD PASI (High Discrimination Psoriasis Area and Severity Index) for target lesion at the end of 4 weeks.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Informed consent will be taken from patient before enrollment, A detailed history including any associated medical condition followed by general physical examination will be done to see any abnormal parameters ,After meeting all inclusion criteria ,enrollment will be done and all baseline photographs will be taken, overall severity score & HD PASI will be calculated patient will be asked to apply film forming spray with steroid ointment on one side and steriod ointment alone on other side for 4 weeks follow up will be done at week1,week2,week4 at every week OSS & HD -PASI assessment will be done ,at week-4 IAGI,PAGI ,CAS assessment would be done |