Health Condition 1: L639- Alopecia areata, unspecified
Conditions
Interventions
Intervention1: Tofacitinib Film Forming Topical Lotion 2% w/v: One ml will be applied twice daily at approximately 12-hour intervals (total daily dose of 2 mL) to the target scalp area of hair loss.
D
Sponsors
Hetero Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 – 50 years of either gender with clinical diagnosis of alopecia areata. 2. Patients in good health with no evidence of systemic illness. 3. Willing to report response to treatment as per protocol during the study period. 4. Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any subject who is currently experiencing significant spontaneous regrowth of terminal hair. 2. Any subject treated with a topical, intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month. 3. Patients who concomitantly using systemic drugs (steroids, cytotoxic agents (methotrexate, azathioprine), vasodilators, antihypertensive agents, anticonvulsant drugs, beta-adrenergic receptor blockers, diuretics, spironolactone, diazoxide, cyclosporine, or ketoconazole. 4. Patients with H / O Tuberculosis or any serious illness. 5. H/ o hypersensitivity to study medication. 6. Participating in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change in SALT score - Percent scalp hair regrowth based on extent of absolute hair loss (percent scalp hair regrowth based on extent of absolute hair loss. (percent scalp hair regrowth based on SALT score).Timepoint: Week 4, week 8 and week 12 (end of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Events (TEAEs)Timepoint: Week 4, Week 8 and Week 12 | — |
Countries
India
Contacts
Public ContactMr P Narender reddy
Hetero Healthcare Limited
Outcome results
None listed