A comparative study evaluating the efficacy of oral tofacitinib versus oral mini pulse of corticosteroids in alopecia areata.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Change in SALT Score.
Study Overview
Brief Summary
Alopecia areata (AA) is an autoimmune disorder which usually presents as non-scarring patches of hair loss. AA comprises nearly one-fourth of all cases of hair loss. It usually starts in childhood but can affect individuals of any age. Unfortunately, there is no cure and no universally proven treatment that induces sustained remission for AA. Various treatment modalities used in alopecia areata are corticosteroids, immunotherapy and PUVA. Out of these, corticosteroids seem to be the most common treatment, however, the use of corticosteroids is associated with many adverse effects. In addition to the adverse effects, the response rate to the steroids varies greatly among patients. Several studies indicate that inhibition of the JAK pathway could be a promising treatment option for severe or progressive alopecia areata. Various retrospective studies and case series show a very promising response of Tofacitinib in the treatment of AA. However, a very few prospective studies have been conducted to compare the efficacy of tofacitinib with conventional treatment used in AA. In this study we will compare the efficacy of tofacitinib versus oral steroid in the management of alopecia areata.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 14.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically diagnosed patient of alopecia areata with more than 20% scalp hair loss or rapidly progressive disease.
- •Age >14 years and <50 years.
Exclusion Criteria
- •Previously treated patients within 2 weeks of topical therapy or 4 weeks of systemic therapy
- •Patients who have hepatic impairment
- •Patients with abnormal blood counts (lymphocyte <500cell/mm3 or neutrophils <1000 cell/mm3)
- •Pregnant and lactating women.
- •Immunocompromised patients or if is a K/C/O Hepatitis B,C,or HIV
- •Patient having an active infection, any systemic illness, uncontrolled diabetes mellitus or hypertension.
Outcomes
Primary Outcomes
Change in SALT Score.
Time Frame: At 4 weeks, 8 weeks, 12 weeks and 16 weeks.
Secondary Outcomes
- 1. Physician global assessment score(2. Patient global assessment score)