Protocol summary
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Study aim
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To evaluate the efficacy and safety of tofacitinib vs azathioprine for the treatment of severe Alopecia areata, Alopecia totalis and Alopecia universalis.
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Design
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randomized, paralled, double blinded study.
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Settings and conduct
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Dermatology Department, Lady Reading Hospital Peshawar, Pakistan.
Care givers, participants, investigators and outcome assessors will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
1.Pateints with >12 years to <60 years age
2. Patients having alopecia areata with ≥50% scalp hair loss, alopecia totalis and alopecia universalis.
3. Stable or worsening disease for ≥6 months
4.Patients must not have received any treatments for the disease under study within 2 months of enrollment and will not be permitted to use any other treatment known to affect the disease under study for the duration of treatment.
Exclusion Criteria:
Following patients will be excluded if they had
1. Active malignancy or a history of malignancy
2. Leukopenia, Anemia
3. Hepatic or renal impairment,
4. Human immunodeficiency virus, Hepatitis B and C.
5. Patients taking systemic immunomodulatory medications
6. Pregnant or nursing women
7. Women of childbearing age who are unwilling or unable to use contraception
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Intervention groups
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Patients in group A will receive tofacitinib at 5mg twice daily for 6 months and patients in group B will receive azathioprine in an oral dose of 1-2 mg/kg/day for 6 months.
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Main outcome variables
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The outcome will be percent change in Severity of Alopecia Tool (SALT)score, calculated by dividing the absolute change in SALT score from the time of treatment initiation to the last evaluation by the initial SALT score. Percent change in SALT score of 100% indicates complete hair regrowth, whereas 0% indicates no regrowth. Treatment will be considered efficacious if percent change in SALT score is > 50%.
General information
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Reason for update
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no reason
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Acronym
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TAA
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IRCT registration information
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IRCT registration number:
IRCT20220904055876N1
Registration date:
2022-09-20, 1401/06/29
Registration timing:
prospective
Last update:
2022-10-29, 1401/08/07
Update count:
1
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Registration date
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2022-09-20, 1401/06/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-04, 1401/07/12
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Expected recruitment end date
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2023-03-04, 1401/12/13
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis.
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Public title
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Tofacitinib and azathioprine in alopecia areata
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients having Alopecia areata with ≥50% scalp hair loss, Alopecia totalis and Alopecia universalis.
Patients must not have received any treatments for Alopecia areata within 2 months of enrollment and will not permitted to use any other treatment known to affect AA
Stable or worsening disease for ≥6 months
Exclusion criteria:
Active malignancy or a history of malignancy
Leukopenia, Anemia
Hepatic or renal impairment
Human immunodeficiency virus, Hepatitis B and C.
Pregnant or nursing women
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Age
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From 12 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Method: Block randomization
Unit: indiviual
Tolls: computer softwares
double blinded
Randomization will be 1:1 for group A and group B, i.e., each upcoming patient will be included in the next group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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participants, care provider, investigator and outcome assessor were blinded. Tablets with same appearance, odor, taste, texture and color but different active substance were used. Only drug manufacturing company was aware of active substance.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-10, 1401/05/19
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Ethics committee reference number
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458/LRH/MTI
Health conditions studied
1
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Description of health condition studied
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Alopecia Areata
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ICD-10 code
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L63
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ICD-10 code description
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Alopecia areata
Primary outcomes
1
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Description
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Severity of Alopecia Tool (SALT) score. Treatment will be considered efficacious if percent change in SALT score is > 50%.
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Timepoint
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before intervention and 3 months and 6 months after intervention
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Method of measurement
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Severity of Alopecia Tool (SALT) score
Intervention groups
1
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Description
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Patients in group A will receive tofacitinib at 5mg twice daily for 6 months and patients in group B will receive azathioprine in an oral dose of 1-2 mg/kg/day for 6 months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Lady reading hospital peshawar
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Grant code / Reference number
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6677
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Lady Reading Hospital Peshawar Pakistan
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis.
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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for people working in academic institutions
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Under which criteria data/document could be used
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no criteria
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From where data/document is obtainable
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contact via email provided previously
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What processes are involved for a request to access data/document
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no process involved
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Comments
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none