A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata
Comparison of the effects of Baricitinib and Tofacitinib in pediatric patients with alopecia areata
Design
After obtaining written consent from the parents, the patients will be randomly divided into 2 groups of 24 people based on the randomization table. The first group will be treated with tofacitinib 5 to 15 mg per day, the second group will be treated with baricitinib 2 to 4 mg per day.
Settings and conduct
After obtaining written consent from the parents, the patients will be randomly divided into 2 groups of 24 people based on the randomization table and the order of entry into the study. The first group will be treated with Tofacitinib 5 to 15 mg per day, the second group will be treated with Baricitinib 2 to 4 mg per day. Clinical and laboratory evaluation intervals will be the first month, the third month, and the sixth month.
Participants/Inclusion and exclusion criteria
This study is a clinical trial and will be conducted on 48 pediatric patients with alopecia areata referred to Razi Hospital under the age of 18. Criteria for entering the study: 1) SALT score above 20% 2) consent of the child's parent and signing the consent form to enter the clinical trial 3) possibility of regular follow-up in the clinic Exclusion criteria: 1) Existence of underlying systemic diseases 2) Parents' lack of consent to systemic treatment 3) SALT score lower than 20
Intervention groups
This study is a clinical trial and will be conducted on 48 pediatric patients with alopecia areata referred to Razi Hospital under the age of 18. After obtaining written consent from the parents, the patients will be randomly divided into 2 groups of 24 people. The first group will be treated with tofacitinib 5 to 15 mg per day, the second group will be treated with baricitinib 2 to 4 mg per day.
Main outcome variables
Disease severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240920063104N1
Registration date:2024-10-12, 1403/07/21
Registration timing:prospective
Last update:2024-10-12, 1403/07/21
Update count:0
Registration date
2024-10-12, 1403/07/21
Registrant information
Name
Alireza Banani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 3928
Email address
alirezabanani1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata
Public title
A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) SALT score above 20%
2) Consent of the child's parent and signing of the consent form to enter the clinical trial
3) Possibility of regular follow-up in the clinic
Exclusion criteria:
Existence of underlying systemic diseases
Parents' lack of satisfaction with systemic treatment
SALT score lower than 20
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a clinical trial and will be conducted on 48 pediatric patients with alopecia areata referred to Razi Hospital under the age of 18. After obtaining written consent from the parents, the patients will be randomly divided into 2 groups of 24 people according to the randomization table. The first group will be treated with tofacitinib 5 to 15 mg per day, the second group will be treated with baricitinib 2 to 4 mg per day.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine - Tehran University of Medical Sciences
Street address
No. 14, 46 Alley, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Approval date
2024-08-19, 1403/05/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.215
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
Comparison of the effects of Baricitinib and Tofacitinib in pediatric patients with alopecia areata
Timepoint
The beginning of the study, 1 month later, 3 months later and 6 months later
Method of measurement
According to clinical examination and SALT score
Secondary outcomes
1
Description
Comparison of the effects of baricitinib and tofacitinib in pediatric patients with alopecia areata
Timepoint
The beginning of the study, one month later, three months later and six months later
Method of measurement
Clinical examination and SALT score
Intervention groups
1
Description
Intervention group:children aged 2 to 18 years with alopecia areata receiving tofacitinib
Category
Treatment - Drugs
2
Description
Intervention group: children aged 2 to 18 years with alopecia areata receiving Baricitinib
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi dermatology hospital
Full name of responsible person
Dr Alireza Banani
Street address
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Phone
+98 21 8803 3928
Email
alirezabanani1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbari Sari
Street address
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Phone
+98 21 8803 3928
Email
alirezabanani1374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Banani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Phone
+98 21 8803 3928
Email
alirezabanani1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Banani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Phone
+98 21 8803 3928
Email
alirezabanani1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Banani
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
City
Tehran
Province
Tehran
Postal code
1436773484
Phone
+98 21 8803 3928
Email
alirezabanani1374@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Total potential data after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific and academic researchers related to the field of dermatology, provided the data source is mentioned
From where data/document is obtainable
alirezabanani1374@gmail.com
What processes are involved for a request to access data/document
Emailing identification documents and purposes of receiving data to the email address: alirezabanani1374@gmail.com Estimated time to send data: 1 week