| CTRI Number |
CTRI/2024/05/067660 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Crisaborole vesus tacrolimus ointment in the treatment of atopic dermatitis |
|
Scientific Title of Study
|
A Comparative evaluation of the efficacy and safety of 2% crisaborole versus 0.1% tacrolimus ointment for the topical treatment of mild to moderate atopic 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 |
Disha Chakraborty |
| Designation |
Senior resident, Department of Dermatology, Calcutta National Medical College and Hospital |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Department of dermatology, skin OPD
32 Gorachand rd beniapukur kolkata 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9674074135 |
| Fax |
|
| Email |
docdishachaks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Disha Chakraborty |
| Designation |
Senior resident, Department of Dermatology, Calcutta National Medical College and Hospital |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
32 Gorachand rd beniapukur
Kolkata
WEST BENGAL
700014
India |
| Phone |
9674074135 |
| Fax |
|
| Email |
docdishachaks@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Chakraborty |
| Designation |
Senior resident, Department of Dermatology, Calcutta National Medical College and Hospital |
| Affiliation |
Calcutta National Medical College and Hospital |
| Address |
Department of Dermatology, skin OPD
32 Gorachand rd beniapukur kolkata 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9674074135 |
| Fax |
|
| Email |
docdishachaks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment hospital Calcutta National Medical college and Hospital, 32 Gorachand Rd Beniapukur kolkata 700014, west bengl,India, free of cost |
|
|
Primary Sponsor
|
| Name |
Dr Disha Chakraborty |
| Address |
32 Gorachand Rd beniapukur kolkata 700014 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Abhishek De |
32 Gorachand Rd beniapukur kolkata 700014 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Disha Chakraborty |
Calcutta National Medical College and Hospital |
Dermatology OPD,32 Gorachand Rd beniapukur kolkata 700014 west bengal
Kolkata
WEST BENGAL |
9674074135
docdishachaks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee calcutta national medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
crisaborole ointment |
2% crisaborole ointment topically for mild to moderate atopic dermatitis twice daily |
| Comparator Agent |
tacrolimus ointment |
0.1% tacrolimus ointment topically for mild to moderate atopic dermatitis twice daily |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients to be aged 2 years or older of either sex
They must have a clinical diagnosis of AD according to Hanifin and Rajka criteria
They should have 5% or more treatable body surface area involvement, and a baseline Investigator’s Static Global Assessment (ISGA) score of mild (2) or moderate (3).
|
|
| ExclusionCriteria |
| Details |
active infections or use of topical steroids in last 14 days |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of 2% crisaborole ointment for treating mild to moderate cases of AD to achieve a clear or near clear skin (ISGA score 0 or 1) at baseline and in 4 weeks. |
At baseline and in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the change in pruritus score with both the treatment groups and compare between them |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| 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="2"
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
|
· Atopic dermatitis (AD) has a high prevalence, approaching 25% in children and 10% in adults, depending on the country of residence.Most patients with AD have mild-to-moderate disease amenable to topical therapy.Treatment of patients with mild and even moderate AD is centered on topical therapies, including emollients, topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs), and a topical phosphodiesterase 4 (PDE4) inhibitors. Use of TCIs and TCSs for long-term disease control might be limited because of side effects, such as skin atrophy (TCSs), local tolerance issues (TCIs), and patient/physician’s reluctance stemming from black box warnings (TCIs).Despite a growing understanding of AD pathomechanisms. No novel topical drugs had been approved for AD in more than a decade until the recent approval of crisaborole. Crisaborole ointment 2% is a nonsteroidal PDE4 inhibitor for the treatment of mild-to-moderate AD. In 2 identically designed, 28-day, phase 3 clinical trials in patients 2 years of age or older with mild-to-moderate AD, crisaborole was well tolerated and superior to vehicle in reducing global disease severity and signs and symptoms of AD. The objective of this study was to determine the efficacy of 2% crisaborole ointment vesus 0.1% tacrolimus ointment for treating mild to moderate cases of AD. |