| CTRI Number |
CTRI/2024/08/072562 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To compare which drug works better in treatment of plaque psoriasis between 2 percent crisaborole cream vs 0.1 percent betamethasone valereate ointment. |
|
Scientific Title of Study
|
A comparative study on the efficacy of topical 2 percent CRISABOROLE Cream vs 0.1 percent BETAMETHASONE VALEREATE Ointment in the treatment of Plaque Psoriasis-A Non Blinded Randomised Control 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 |
Dr Guruprakash A V |
| Designation |
Post graduate |
| Affiliation |
Government Stanley Medical College and Hospitak |
| Address |
Department of Dermatology Venereology Leprosy
Government stanley medical college and hospital
No.1 old jail road, George town
Chennai-600001
Chennai
TAMIL NADU
600001
India |
| Phone |
7373696877 |
| Fax |
|
| Email |
guruprakash156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anandan V |
| Designation |
Head of the Department |
| Affiliation |
Government Stanley Medical College and Hospital |
| Address |
Department of Dermatology Venereology Leprosy
Government Stanley Medical College and Hospital
No.1 old jail road, George town
Chennai-600001
Chennai
TAMIL NADU
600001
India |
| Phone |
9841043213 |
| Fax |
|
| Email |
dermanandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Guruprakash A V |
| Designation |
Post Graduate |
| Affiliation |
Government Stanley Medical College and Hospital |
| Address |
Department of Dermatology Venereology Leprosy
Government Stanley Medical College and Hospital
No.1 old jail road, George town
Chennai-600001
Chennai
TAMIL NADU
600001
India |
| Phone |
7373696877 |
| Fax |
|
| Email |
guruprakash156@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology Venereology Leprosy
Government Stanley Medical College and Hospital
No.1 old jail road, George town
Chennai-600001
|
|
|
Primary Sponsor
|
| Name |
GURUPRAKASH A V |
| Address |
DEPARTMENT OF DERMATOLOGY VENEREOLOGY AND LEPROSY,
GOVERNMENT STANLEY MEDICAL COLLEGE,
No.1. OLD JAIL ROAD,GEORGE TOWN,CHENNAI-600001 |
| 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 Guruprakash A V |
Government Stanley Medical College and Hospital |
Department of Dermatology Venereology and Leprology,
OP no-81,
First floor SSB(H) Block
Chennai
TAMIL NADU |
7373696877
guruprakash156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT STANLEY MEDICAL COLLEGE AND HOSPITAL,CHENNAI-01 INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.1 percent Betamethasone valereate Ointment |
0.1 percent Betamethasone Valereate ointment is applied over the lesion twice daily for 4 weeks and once daily for next 4 weeks.
|
| Intervention |
2 Percent Crisaborole Cream |
2 Percent Crisaborole Cream is applied over the lesion twice daily for 4 weeks ,once daily for next 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient clinically diagnosed as Psoriasis vulgaris with less than 10 percent Body Surface Area involvement.
2.Age above 12 years
3. Patient willing for consent , study and follow up.
4. Patient willing to take clinical photos.
5. Patient not on any other treatment with topical and systemic drugs for Psoriasis for at least past 1 month.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 12 years.
2.Patients with Psoriasis involving more than 10 percent Body Surface Area.
3.Patients with Severe Psoriasis Vulgaris and Erythrodermic Psoriasis, Pustular Psoriasis, Guttate Psoriasis, Nail Psoriasis, Psoriatic Arthritis.
4.Patients who are on treatment with topical or systemic drugs specific to Psoriasis within past 1 month.
5.Patients with active infection at the study site.
6.Patient not willing for regular follow-up or to take clinical pictures.
7.Lactating or Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Resolution of psoriatic plaque assessed by PASI score
|
Every week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Remission of the Psoriatic Plaque |
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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 Applicable |
| 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
|
It is a Non-Blinded Randomised Control Study. Selected
patients who fulfil the inclusion criteria will be included in the study. After
clinical diagnosis of Psoriasis Vulgaris patients will be randomized into two
groups A and B
.Patients in group A will
receive topical 2 percent Crisaborole cream twice daily for 4 weeks and tapered
to once daily for next 2 weeks and once daily on alternative days for next 2
weeks. After stopping treatment on week 8 , patient will be followed up on 10th
and 12th week to look for
recurrence and adverse events if any.
Patients in group B will
receive topical 0.1 percent Betamethasone Valereate ointment twice daily for 4
weeks and tapered to once daily for next 2 weeks and once daily on alternative
days for next 2 weeks. After stopping treatment on week 8, patient will be
followed up on 10th and 12th week to look for recurrence
and adverse events if any. |