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

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.