Comparative study of efficacy and tolerability of topical therapy with 0.03% Tacrolimus cream versus 2% Tofacitinib ointment in patients of Alopecia Areata single patch in a tertiary care teaching hospital: A prospective, observational study.

Title of the Study Comparative study of efficacy and tolerability of topical therapy with 0.03 percent Tacrolimus 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. It has an unpredictable relapsing course, impacts quality of life and is associated with genetic and immunological factors. Standard therapy includes corticosteroids and topical tacrolimus. Janus kinase inhibitors such as tofacitinib are emerging as effective alternatives. Few head to head studies are available hence this study is planned

Purpose of the Study To compare the efficacy and tolerability of topical 2 percent tofacitinib ointment versus 0.03 percent tacrolimus cream in single patch alopecia areata patients

Objectives Primary objective To compare efficacy using Severity of Alopecia Tool SALT score from baseline to 24 weeks

Secondary objectives 1 To compare tolerability by recording adverse drug reactions 2 To assess and compare quality of life using Dermatology Life Quality Index DLQI at 24 weeks

Methodology a Materials and Methods Prospective observational comparative study conducted in Department of Dermatology at GMC Nagpur for 24 months June 2025 to May 2027. Patients with single patch alopecia areata will be enrolled

b Inclusion Criteria Age 18 to 50 years Stable single patch alopecia areata for at least 6 months patch size less than or equal to 5 cm Treatment naive or washed out from prior treatment for 4 weeks Written informed consent

c Exclusion Criteria Multiple or diffuse patches History of autoimmune systemic or endocrine disorders Use of systemic immunosuppressants Known hypersensitivity to study drugs History of cancer positive serology for HBV HCV HIV or latent TB Pregnant or lactating women

d Endpoints Primary endpoint Change in composite SALT score from baseline to 24 weeks Secondary endpoints Safety assessed by adverse events and change in DLQI score

e Outcomes Primary outcome Improvement in SALT score and percentage hair regrowth Secondary outcomes Incidence of adverse effects and improvement in DLQI score

Study Procedure Screening and diagnosis by dermatologist informed consent taken allocation into two groups Group A topical 2 percent tofacitinib twice daily Group B topical 0.03 percent tacrolimus once daily. Duration 24 weeks follow up at 2 8 and 24 weeks in person and 4 12 weeks telephonically. Efficacy assessed by SALT score tolerability by adverse event reporting and QoL by DLQI

Drug Availability Drugs will be provided free of cost through hospital OPD no financial burden on participants

Final Synopsis Sayali-AA Tofa v…

Data Collection Demographics baseline clinical parameters SALT score DLQI recorded at baseline and follow ups. Data entered in case record form and analysed

Statistical Analysis Continuous variables analysed using Student t test categorical variables with Chi square or Fisher exact test p value less than 0.05 considered significant. Mann Whitney and Friedman test used for intra and inter group comparisons. Analysis by Graph Pad Prism v8.4.2

Ethical Considerations Conducted as per Declaration of Helsinki GCP guidelines IEC approval obtained written informed consent confidentiality maintained right to withdraw ensured

Expected Impact The study is expected to provide comparative evidence on efficacy and tolerability of topical tofacitinib versus tacrolimus in alopecia areata and guide clinical decision making for better patient outcomes