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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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