Efficacy of azelaic acid 20% and anthralin 1% In patients with alopecia areata
Design
Clinical trial, randomized, without blinding, with parallel groups on 60 patients
Settings and conduct
The present study will be performed in Sina Hospital in Tabriz. Patients will be randomly studied in two groups without blinding using a sealed eraser. Patients' recovery will be assessed. Patient recovery is defined as new hair growth that has a complete therapeutic response (above 90% of terminal hair), moderate (between 50% and 90% of terminal hair), low (between 10% and 50% of terminal hair) and no response (less than 10%). Terminal hair) will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria included alopecia areata scalp, failure to receive treatment during the previous month and consent to the study and exclusion criteria including pregnant women, receiving effective treatments for alopecia areata and corticosteroid and immunosuppressive and immunomodulatory drugs in Over the past month, Alopecia areata has been in a location other than the scalp and Alopecia areata Universalis and dissatisfaction with the study.
Intervention groups
In the group treated with 1% anthralin (dissolved in Vaseline), treatment will be started for 10 days. In order to cause mild inflammation, the duration of use will be increased by 10 minutes every 4 days. For patients who do not develop mild inflammation after 60 minutes, treatment will be considered overnight (for 8 hours). The group treated with 20% azelaic acid will be rubbed twice a day until they recover and for a maximum of 6 months in the areas of hair loss.
Main outcome variables
Patient recovery rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002581N8
Registration date:2022-06-29, 1401/04/08
Registration timing:prospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of azelaic acid 20% versus anthralin 1% in patients with scalp alopecia areata
Public title
Efficacy of azelaic acid 20% versus anthralin 1% in scalp alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having alopecia areata scalp
Not receiving treatment during the previous month
Consent for the study
Exclusion criteria:
Pregnant women
Receiving effective treatments for alopecia areata taking corticosteroids and immunosuppressants and immunomodulators during the past month
Alopecia areata in a location other than the scalp and Alopecia areata universalis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be using sealed envelopes, of which 60 envelopes will be selected in total and will be divided into two groups of 30, including groups A and B.
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
Vice Chancellor for research of Tabriz Univercity of Medical Sciences
Street address
Vice Chancellor for research, 3rd floor, central office, Tabriz Univercity of Medical Sciences, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
515431232
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.TBZMED.REC.1401.293
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
Patient recovery rate
Timepoint
Every month after intervention for 6 months
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anthralin 1% treatment group (dissolved in Vaseline) The treatment will start with the use for 10 minutes a day. In order to cause mild inflammation, the duration of use will be increased by 10 minutes every 4 days. For patients who do not develop mild inflammation after 60 minutes, treatment will be considered overnight (for 8 hours).
Category
Treatment - Drugs
2
Description
Intervention group: The group treated with 20% azelaic acid will be rubbed twice a day until they recover and for a maximum of 6 months in the areas of hair loss.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Hamideh Herizchi Ghadim
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Fax
+98 41 8406 3549
Email
Drherizchi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ataa Mahmoudpour
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 8236 3549
Email
Drherizchi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamideh Herizchi Ghadim
Position
Dermatologist Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
Email
dr.herizchi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamideh Herizchi Ghadim
Position
Dermatologist Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
Email
dr.herizchi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamideh Herizchi Ghadim
Position
Dermatologist Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Dermatology ward, sina Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
Email
dr.herizchi@yahoo.com
Web page address
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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.