Comparative study of efficacy and tolerability of topical 0.1 percent Mometasone furoate cream versus 2 percent Tofacitinib ointment in patients of Alopecia areata (single patch) in a tertiary care teaching hospital: A prospective, observational study.

Title: Comparative study of efficacy and tolerability of topical therapy with 0.1%  Mometasone cream versus 2 percent Tofacitinib ointment in patients of Alopecia Areata single patch in a tertiary care teaching hospital A prospective observational study Introduction: Alopecia areata is a common autoimmune dermatosis characterized by non-scarring hair loss that can affect social and psychological well-being It most often presents as single or multiple round or oval patches Topical mometasone and topical tofacitinib are emerging nonsteroidal options targeting the underlying autoimmune pathology Most available evidence compares each separately but head to head comparator data is limited Objectives: Primary objective To compare the efficacy of topical 2 percent Tofacitinib ointment versus 0.1% Mometasone cream in patients of alopecia areata using Severity of Alopecia Tool SALT score from baseline to 24 weeks Secondary objectives To compare the tolerability of both treatments by monitoring for adverse drug reactions To assess and compare patient quality of life using the Dermatology Life Quality Index DLQI at end of 24 weeks Methodology: a) Materials and Methods This is a prospective observational comparative study to be conducted over a period of 24 months in a tertiary care teaching hospital Patients diagnosed with single patch alopecia areata will be allocated to either Group A topical 2 percent Tofacitinib ointment applied twice daily or Group B topical 0.1% Mometasone cream applied once daily for 24 weeks b) Inclusion Criteria Patients aged 18 to 50 years Stable single patch alopecia areata of less than or equal to 5 cm size persisting for at least six months Willingness to provide written informed consent Treatment naive or with at least four weeks washout of prior topical or systemic AA therapy c) Exclusion Criteria Multiple patches or diffuse alopecia History of autoimmune systemic or endocrine disorders Current use of systemic immunosuppressants or corticosteroids Known hypersensitivity to study drugs History of cancer Positive tests for hepatitis B or C HIV or tuberculosis Pregnancy or lactation d) Endpoints Primary endpoint Difference in composite SALT score from baseline to 24 weeks Secondary endpoints Incidence and severity of adverse effects Change in DLQI between baseline and 24 weeks e) Primary Outcome Mean percentage improvement in patch area or SALT score at week 24 f) Secondary Outcomes Number of patients achieving 60 percent or more regrowth Improvement in DLQI score Time to visible hair regrowth Incidence of adverse events Study Procedure: Patients screened in dermatology OPD and those fulfilling inclusion and exclusion criteria are enrolled after written informed consent Baseline demographic and clinical data including blood counts are recorded Participants are randomly allocated to either group Each group is given the assigned intervention for 24 weeks with in person follow up at weeks 2 8 and 24 and telephonic follow up at weeks 4 and 12 SALT and DLQI scores are recorded by a dermatologist Drug Availability: Both medications are provided free of cost to study participants through the OPD pharmacy Data Collection: Demographic and clinical data including serial SALT and DLQI scores are recorded at each follow up Adverse events are monitored at each contact Statistical Analysis: Continuous variables are compared using students t test and categorical data using chi square or fishers exact test Mann Whitney test is used for independent means and Friedmans test for within group SALT score reduction P value less than 0 05 is considered statistically significant Analysis is performed using Graph pad prism software Ethical Consideration: Expected Impact: Institutional Ethics Committee approval is obtained Study is conducted as per Declaration of Helsinki guidelines Participants rights to confidentiality and withdrawal are protected Written informed consent is mandatory Drugs are provided at no cost This study will provide comparative data on efficacy and safety of topical mometasone versus tofacitinib for single patch alopecia areata thereby informing evidence based therapeutic choices in clinical practice