Health Condition 1: L638- Other alopecia areata
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: NOT APPLICABLE
Exclusion criteria
Exclusion criteria: Multiple patches or diffuse alopecia. History of autoimmune, systemic, or endocrine disorders (e.g., SLE, thyroid disease). Current use of systemic immunosuppressants or corticosteroids. Patient known for study drug hypersensitivity reaction. History of cancer. Positive tests for hepatitis B or C virus, tuberculin skin test, QuantiFERON TB test, and human immunodeficiency virus. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the difference in the composite Severity of Alopecia Tool (SALT) scale from baseline to 24 weeks.Timepoint: At the end of 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety assessment done by recording and evaluating the spontaneously reported adverse events by the participants. 2. To assess and compare patient s quality of life (QoL) using Dermatology Life Quality Index (DLQI) from baseline to 24 weeks between two groups Timepoint: The secondary efficacy endpoint will be the difference in the Dermatology Life Quality Index (DQLI) from baseline to 24 weeks. | — |
Countries
India
Contacts
GMC Nagpur