| CTRI Number |
CTRI/2025/09/094291 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Crisaborole Ointment as a long term solution for Chronic Hand Eczema |
|
Scientific Title of Study
|
Efficacy of Crisaborole Ointment as Maintenance Therapy in Chronic Hand Eczema |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavana S |
| Designation |
Post graduate resident |
| Affiliation |
J.J.M Medical College |
| Address |
Department of Dermatology, J.J.M Medical College, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9620077979 |
| Fax |
|
| Email |
kavanashivmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmya Manangi |
| Designation |
Associate professor |
| Affiliation |
J.J.M Medical College |
| Address |
Department of Dermatology, J.J.M Medical College, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9019469388 |
| Fax |
|
| Email |
yellowindia.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sowmya Manangi |
| Designation |
Associate professor |
| Affiliation |
J.J.M Medical College |
| Address |
Department of Dermatology, J.J.M Medical College, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9019469388 |
| Fax |
|
| Email |
yellowindia.m@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kavana S |
| Address |
Department Of Dermatology, J.J.M Medical college, Davangere, Karnataka 577004 |
| 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 Kavana S |
J.J.M Medical College |
Room No 9, Out patient Department of Dermatology, J.J.M Medical College, MCC B block, Davangere 577004
Davanagere
KARNATAKA |
9620077979
kavanashivmurthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JJM Medical College, Davangere, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L249||Irritant contact dermatitis, unspecified cause, (2) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, (3) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Crisaborole 2% Ointment |
Twice daily application over affected areas for 12 weeks |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Diagnosed with Chronic hand eczema |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years.
2. Patients previously treated with PDE4 inhibitors for the same
3. Pregnant & lactating women.
4. Patient who do not give consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean improvement score by physician (MISP) by two dermatologists using a quartile grading scale |
At baseline, week 2, week 4, week 8, week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patients’ satisfaction at the end of the study using a
10-point Visual Analogue Scale (VAS) |
At week 12 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/09/2025 |
| 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 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
|
Hand eczema is a common, often chronic condition with significant personal and occupational impact. Crisaborole is a non-steroidal PDE4 inhibitor with anti-inflammatory properties and favorable safety profile, making it a promising alternative for long-term use. This is a Prospective interventional, single-arm study to evaluate the efficacy of Crisaborole 2% ointment as a maintenance therapy in patients with chronic hand eczema. 35 patients with chronic hand eczema satisfying inclusion criteria will receive Clobetasol cream until lesions improve by about 70% followed by Crisaborole 2% ointment applied twice daily for 12 weeks. Mean improvement score by physician and Patient satisfaction will be assessed at2,4,8, 12 weeks. Safety and any side effects will also be monitored. The results may help determine if Crisaborole can be a safer long-term treatment option for chronic hand eczema. |