This study aims to compare efficacy of oral tofacitinib with oral prednisolone in treatment of moderate to severe Alopecia Areata
Design
Randomized, parallel double blinded study
Settings and conduct
Participants meeting the inclusion criteria will be allocated into two groups by lottery method of randomization. Prior to start of medication SALT score, digital photographs and Laboratory tests will be done. Group A will receive oral Tofacitinib 5 mg (twice daily)' for three months, Group B will receive oral Prednisolone 0.5 mg/Kg for 6 Weeks and then tapered very slowly over next six weeks for three months. Participants will be blinded to what treatment they are getting. Regrowth will be assessed using photographic assessment and salt score at Week 2, 6, 10 and 12 Weeks. Laboratory tests will be repeated monthly. Any adverse effect, recurrence and compliance will also be documented. Study will be conducted at CMH Quetta, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: clinical diagnosis of alopecia areata with SALT score of 25 % or more; age 15-59 years old; no other treatment for AA taken in last 3 months. Exclusion criteria: history of severe systemic diseases (Hepatic, renal, pulmonary and cardiovascular); pregnant or lactating mother. Those with other causes of hair loss; androgenetic alopecia, telogen effluvium, trichotillomania and cicatricial alopecia. Hypersensitivity to medications. Patients who are immunodeficient or undergoing immunosuppressive therapy.
Intervention groups
Group A: Oral Tofacitinib 5 mg (twice daily)' for three months. Group B: Oral Prednisolone 0.5 mg/Kg for 6 Weeks and then tapered slowly over next six weeks
Main outcome variables
Outcome will be ascertained on the basis of reduction in Severity of Alopecia Tool (SALT) score from base line, Photographic assessment and laboratory tests.
General information
Reason for update
Acronym
AA Alopecia Areata
IRCT registration information
IRCT registration number:IRCT20210823052264N12
Registration date:2024-12-19, 1403/09/29
Registration timing:registered_while_recruiting
Last update:2024-12-19, 1403/09/29
Update count:0
Registration date
2024-12-19, 1403/09/29
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-13, 1403/09/23
Expected recruitment end date
2025-03-13, 1403/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Oral Tofacitinib and Oral Prednisolone in moderate to severe Alopecia Areata - A comparative study
Public title
Efficacy of Oral Tofacitinib and Oral Prednisolone in moderate to severe Alopecia Areata - A comparative study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of alopecia areata with SALT score of 25 % or more
Age Range 15-59 years
Patients who have not taken oral, topical or systemic treatment for alopecia areata within 3 months prior to study
Exclusion criteria:
History of severe systemic diseases (Hepatic, renal, pulmonary and cardiovascular)
Pregnant or nursing mother
Those with other causes of hair loss; androgenetic alopecia, telogen effluvium, trichotillomania and cicatricial alopecia
Hypersensitivity to medications
Patients who are immunodeficient or undergoing immunosuppressive therapy
Age
From 15 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with lottery method using sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study (Participants and data analyzer are blinded)