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Effectiveness of tofacitinib versus Betamethasone in alopecia areata.

Completed
Conditions
Alopecia areata, unspecified,
Registration Number
CTRI/2022/12/048004
Lead Sponsor
All India Institute of Medical Sciences, Jodhpur
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
82
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 2.
  • Patients who have hepatic impairment 3.
  • Patients with abnormal blood counts (lymphocyte <500cell/mm3 or neutrophils <1000 cell/mm3) 4.
  • Pregnant and lactating women.
  • Immunocompromised patients or if is a K/C/O Hepatitis B,C,or HIV 6.
  • Patient having an active infection, any systemic illness, uncontrolled diabetes mellitus or hypertension.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in SALT Score.At 4 weeks, 8 weeks, 12 weeks and 16 weeks.
Secondary Outcome Measures
NameTimeMethod
1. Physician global assessment score2. Patient global assessment score

Trial Locations

Locations (1)

OPD, Department of Dermatology, Venereology and Leprology

🇮🇳

Jodhpur, RAJASTHAN, India

OPD, Department of Dermatology, Venereology and Leprology
🇮🇳Jodhpur, RAJASTHAN, India
Dr Akhilesh Kumar Vimal
Principal investigator
9835198515
akhileshvl62@gmail.com

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