| CTRI Number |
CTRI/2025/10/096319 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To look for effect of mometasone furoate ointment 0.1 percent between crisaborole 2 percent ointment, tofacitinib 2 percent ointment twice daily in mild to moderate atopic dermatitis. |
|
Scientific Title of Study
|
A randomized assessor blinded triple arm pilot study to compare the efficacy of mometasone furoate 0.1 percent ointment versus crisaborole 2 percent ointment versus tofacitinib 2 percent ointment twice daily in patients with 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 |
Neetu Bhari |
| Designation |
Faculty, Department of dermatology and venereologyy |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 4070, academic block, All India Institute of Medical Sciences, Ansari nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
drntbhari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shreya K |
| Designation |
Senior resident, Department of dermatology and venereology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 308, New RAK OPD, Department of dermatology, All India Institute of Medical Sciences, New Delhi
New Delhi DELHI 110029 India |
| Phone |
8296529521 |
| Fax |
|
| Email |
shreyakgowda@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shreya K |
| Designation |
Senior resident Department of dermatology, and venereology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room 308, New RAK OPD, Department of dermatology, All India Institute of Medical Sciences, Ansari nagar New Delhi
New Delhi DELHI 110029 India |
| Phone |
8296529521 |
| Fax |
|
| Email |
shreyakgowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil monetary support
Study conducted in All India Institute of Medical Sciences, New Delhi, Ansari Nagar. New Delhi, 110029, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Shreya K |
All India Institute of Medical Sciences, New Delhi |
Room 308, New RAK OPD, Department of dermatology, Ansari Nagar, All India Institute of Medical Sciences, New Delhi New Delhi DELHI |
8296529521
shreyakgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20||Atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
crisaborole 2 percent ointment |
crisaborole 2 percent ointment twice daily local application over lesions for 12 weeks |
| Intervention |
Mometasone 0.1 percent ointment |
Mometasone 0.1 percent ointment twice daily topical application over lesions for 12 weeks |
| Comparator Agent |
tofacitinib 2 percent ointment |
tofacitinib 2 percent ointment twice daily local application over lesions for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Atopic dermatitis fulfilling Hanifin Rajka criteria |
|
| ExclusionCriteria |
| Details |
Current active herpes zoster, and bacterial infection, with prior oral immunosuppressants within 4 weeks, and topical steroids within 2 weeks of recruitment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of patients showing 75 percent reduction in EASI score with mometasone furoate 0.1 percent ointment versus crisaborole 2 percent ointment versus tofacitinib 2 percent ointment once daily in patients of mild to moderate atopic dermatitis |
at baseline, 4 weeks, 8 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess the severity of pruritus (NRS) at baseline, 4 weeks, 8 weeks and the end (12 weeks) of therapy among three groups. |
baseline, 4, 8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
21/12/2025 |
| 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="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
|
Patients with atopic
eczema with body surface area less than 5%, age more than 2 years, of any
gender, attending the allergy clinic and dermatology OPD, AIIMS, New Delhi.
Sample size: 15 in each group (pilot study).
Methodology This is an assessor-blinded, randomized controlled study
to compare the efficacy of mometasone furoate 0.1% ointment versus crisaborole 2%
ointment versus tofacitinib 2% ointment in patients with atopic eczema, age
above 2 years of any gender. Patients fulfilling inclusion criteria will be
recruited and randomly allocated into three groups (1:1:1) based on a random
allocation table.
Blinding and
allocation concealment:
The three ointment
tubes with prenumbered with coded identical tubes will be dispensed by the
investigator (Dr Shreya K) as per the randomization list, and thereby patient
concealment in ensured. The assessor (Dr Neetu Bhari) will assess the EASI,
NRS, DLQI, number of flares, patient satisfaction score, and adverse events in
both groups. Therefore, the assessor blinding is ensured.
The patients are
advised to apply the 0.5-gram ointment over 1 percent of body surface area once
daily. Apart from these, routine skin care, liquid paraffin moisturizer, and
antihistamines (Tablet levocetrizine 5 mg once to twice daily) will be added.
The EASI score, BSA,
number of flares, side effects, and clinical photographs will be analyzed at
baseline, 4 weeks, 8 weeks and the end of therapy (12 weeks). DLQI, NRS, will
be assessed at baseline and the end of therapy while the patient
satisfaction score will be assessed at the end of therapy.
5.2. Inclusion
criteria: Patients with age 2 to 60 years, with a clinically diagnosed case
of atopic dermatitis diagnosed based on Hanifin and Rajka criteria with
involvement of BSA <5% involving areas other than scalp.
5.3. Exclusion
criteria:
Current
active herpes zoster, and bacterial infection, with prior oral
immunosuppressants within 4 weeks, and topical steroids within 2 weeks of
recruitment will be excluded. |