Health Condition 1: L661- Lichen planopilaris
Conditions
Interventions
Intervention1: Oral Tofacitinib: Oral Tofacitinib 5 mg twice daily
Control Intervention1: Oral Methotrexate: Oral Methotrexate 0.3 mg/kg/week (maximum 25 mg/week) along with Folic acid 5 mg once weekl
Sponsors
Department of DermatologyVenereology and Leprology PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age more than or equal to 18 years 2.Biopsy proven lichen planopilaris of scalp 3.All consecutive eligible patients with lichen planopilaris of the scalp presenting to the Dermatology Outpatient Department of PGIMER, Chandigarh during the study period will be recruited into the study irrespective of disease severity or duration. 4.Either treatment naive or with inadequate or partial response to earlier therapy , after ensuring a washout of 4 weeks for systemic agents and 2 weeks for topical agents will be enrolled in the study. 5.Willingness to attend regular follow up visits for atleast 12 months
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation, or women of reproductive age unwilling to adhere to reliable contraception or planning pregnancy during the study period. 2. Presence of active or latent tuberculosis. 3. Severe systemic comorbidities, including but not limited to: Severe hepatic or renal impairment or other significant organ dysfunction Cardiac failure, ischemic heart disease, or stroke Uncontrolled diabetes mellitus Chronic lung disease Active infections including AIDS 4. Abnormal laboratory parameters Leukocyte count less than 4000 per cubic millimetres Hemoglobin less than 9 grams per decilitre Platelet count less than 100000 per cubic millimetres Liver enzymes more than two times upper limit of normal Uncontrolled dyslipidemia Impaired renal function 5. Pre-existing malignancy, bone marrow suppression, or a history of thromboembolic events. 6. No concurrent systemic immunosuppressants 7. Positive viral serology i.e. HBV, HCV, HIV 8. Inability or unwillingness to provide informed consent or comply with scheduled follow-ups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the mean change in LPPAI at 24 weeks between patients receiving oral tofacitinib vs oral methotrexate.Timepoint: Mean change in LPPAI will be determined at 24 weeks and LPPAI will be assessed at baseline,4 weeks, 8 weeks, 12 weeks and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the proportion of participants achieving at least a 50 percent reduction in LPPAI score from baseline in both the groups at 24 weeks. Timepoint: LPPAI will be assessed at baseline,4 weeks, 8 weeks, 12 weeks and 24 weeks and the proportion of participants achieving at least 50 percent reduction in LPPAI score from baseline will be determined at 24 weeks;To compare trichoscopic features at baseline and 24 weeks in both the groups. Timepoint: Trichoscopic assessment will be done at baseline and 24 weeks and features on trichoscopy will be compared;To compare the adverse effects in both the groups during the course of treatment.Timepoint: Assessment of safety & tolerability (adverse events, laboratory parameters, & treatment discontinuation) will be performed at baseline, 2 weeks , 4 weeks, 8 weeks , 12 weeks and 24 weeks with ongoing monitoring throughout the study duration.;To compare the mean change in DLQI score at 24 weeks in both the groupsTimepoint: DLQI will be assessed at baseline and 24 weeks and mean change will be determined at 24 weeks;To compare the change in JAK STAT pathway expression in scalp biopsy tissue and blood from baseline to week 24 between the two groups. Timepoint: For JAK STAT pathway expression, Ribonucleic acid will be isolated from blood and scalp biopsy at baseline and at 24 weeks and analysed for the expression of JAK STAT | — |
Countries
India
Contacts
Public ContactDr Saumya Singh
Postgraduate Institute of Medical Education and Research , Chandigarh
Outcome results
None listed