To evaluate the efficacy and safety of tofacitinib vs azathioprine for the treatment of severe Alopecia areata, Alopecia totalis and Alopecia universalis.
Design
randomized, paralled, double blinded study.
Settings and conduct
Dermatology Department, Lady Reading Hospital Peshawar, Pakistan.
Care givers, participants, investigators and outcome assessors will be blinded.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
TAA
IRCT registration information
IRCT registration number:IRCT20220904055876N1
Registration date:2022-09-20, 1401/06/29
Registration timing:prospective
Last update:2022-09-20, 1401/06/29
Update count:1
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
Farah Sagheer
Name of organization / entity
Lady Reading Hospital Peshawar Pakistan
Country
Pakistan
Phone
+92 321 9049707
Email address
farah.sagheer@lrh.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-04, 1401/07/12
Expected recruitment end date
2023-03-04, 1401/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis.
Public title
Tofacitinib and azathioprine in alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lady Reading Hospital Peshawar
Street address
Dermatology Department, Lady Reading Hospital Peshawar, Pakistan.
City
Peshawar
Postal code
45666
Approval date
2022-08-10, 1401/05/19
Ethics committee reference number
458/LRH/MTI
Health conditions studied
1
Description of health condition studied
Alopecia Areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
Severity of Alopecia Tool (SALT) score. Treatment will be considered efficacious if percent change in SALT score is > 50%.
Timepoint
before intervention and 3 months and 6 months after intervention
Method of measurement
Severity of Alopecia Tool (SALT) score
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Lady Reading Hospital Peshawar, Pakistan
Full name of responsible person
Farah Sagheer
Street address
Lady Reading Hospital Peshawar Pakistan
City
Peshawar
Postal code
45666
Phone
+92 321 9049707
Email
farah.sagheer@lrh.edu.pk
Web page address
https://pubmed.ncbi.nlm.nih.gov/21616562/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lady Reading Hospital Peshawar Pakistan
Full name of responsible person
Farah Sagheer
Street address
Lady Reading Hospital Peshawar Pakistan
City
Peshawar
Postal code
45666
Phone
+92 321 9049707
Email
farah.sagheer@lrh.edu.pk
Grant name
Lady reading hospital peshawar
Grant code / Reference number
6677
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lady Reading Hospital Peshawar Pakistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Lady Reading Hospital Peshawar Pakistan
Full name of responsible person
Farah Sagheer
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Lady Reading Hospital, Peshawar, Pakistan
City
Peshawar
Province
Khyber pukhtunkhwa
Postal code
45666
Phone
+92 321 9049707
Fax
Email
farah.sagheer@lrh.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lady Reading Hospital Peshawar Pakistan
Full name of responsible person
Farah Sagheer
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Lady Reading Hospital, Peshawar, Pakistan
City
Peshawar
Province
Khyber pukhtunkhwa
Postal code
45666
Phone
+92 321 9049707
Fax
Email
farah.sagheer@lrh.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Lady Reading Hospital Peshawar Pakistan
Full name of responsible person
Farah Sagheer
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Lady Reading Hospital, Peshawar, Pakistan
City
Peshawar
Province
Khyber pukhtunkhwa
Postal code
45666
Phone
+92 321 9049707
Fax
Email
farah.sagheer@lrh.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Efficacy and safety of Tofacitinib versus Azathioprine in severe alopecia areata, alopecia universalis and alopecia totalis.
When the data will become available and for how long
6 months after publication
To whom data/document is available
for people working in academic institutions
Under which criteria data/document could be used
no criteria
From where data/document is obtainable
contact via email provided previously
What processes are involved for a request to access data/document