Evaluation of the efficacy and side effects of intralesional methotrexate injection in comparison with intralesional triamcinolone acetonide in patients with alopecia areata in patients referred to Razi Hospital in 2021-2022
Efficacy and side effects of intralesional methotrexate injection in comparison with intralesional triamcinolone acetonide in patients with alopecia areata in patients referred to Razi Hospital in 2020-2021
Design
Two arm parallel group randomized double-blind clinical trial, phase 3 on 40 patients.Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Patients with alopecia areata referred to Razi Hospital who met the necessary criteria to enter the study were divided into two groups receiving intralesional methotrexate and intralesional triamcinolone acetonide. The study is double blind and the patient and clinical assessors are blinded.
Participants/Inclusion and exclusion criteria
The inclusion criteria for adult patients (aged 60-16 years) with patchy alopecia areata that involve less than 20% of the skin surface and the presence of areata patches on both sides of the head with a size of at least 10 square meters (both sides are patchy and relatively It should be similar and if there is aphiasis on both sides.) and they have not received any treatment for AA in the last 1 month.
Exclusion criteria include children and patients under 16 years of age, pregnant and lactating women, chronic patients including patients with liver or blood disorders, patients with immunodeficiencies, infectious diseases, patients with widespread types (alopecia totalis, alopecia universalis and involvement is more than 20%) and patients who were treated for alopecia areata during the previous 1 month.
Intervention groups
Patients were randomly divided into control and intervention groups. The intervention group received intralesional methotrexate and the control group received intralesional triamcinolone acetonide.
Main outcome variables
Hair regrowth rate,change in SALT score before and after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020250N6
Registration date:2023-05-29, 1402/03/08
Registration timing:retrospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Narges Ghandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
nghandi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and side effects of intralesional methotrexate injection in comparison with intralesional triamcinolone acetonide in patients with alopecia areata in patients referred to Razi Hospital in 2021-2022
Public title
Intralesional methotrexate injection in alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (aged 16-60 years)
Patients with alopecia areata who have less than 20% involvement of the scalp
have not received any treatment for AA in the past 1 month.
Exclusion criteria:
Children and patients under 16 years, pregnant and lactating women, chronic patients including patients with liver or blood disorders, patients with immunodeficiency, infectious disease
patients with diffuse types (alopecia totalis, alopecia universalis and more than 20%) and positive pull tests that are candidates for systemic treatment
patients who were treated for alopecia areata during the previous month
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control groups
Limited randomization (Random Allocation Law)
Randomization unit: individual
The law of random assignment is the simplest method of limited randomization. This method represents a large block for the entire sample volume, which means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, the researchers first determined a total sample size, then randomly selected groups assign them to group A and the rest to group B. For example, in a study with a sample size of 200 people, 100 balls for intervention group A and 100 balls for intervention group B are placed in a lottery container and then The balls are randomly removed from the container without replacement and the created sequence is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
A double-blind study is a study in which neither the participant nor the experimenter knows who is receiving which treatment. This method is used to prevent bias in the results. Double-blind research helps to reduce the effects of people's orientation on the research. This orientation can include the unwanted influence of the researcher on the way of collecting information or dividing people into groups. Researchers sometimes unintentionally interfere in the research process due to their feelings about the research path or personal interest in obtaining a specific result.
Double-blind studies are usually conducted on humans, the factors that can bias the results of the experiment remain hidden from both the participant and the experimenter (or experimenters). In most cases, double-blind tests are performed in order to achieve a higher scientific standard.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of medical sciences
Street address
Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-02-12, 1400/11/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1311
Health conditions studied
1
Description of health condition studied
Alopecia Areata
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Alopecia Areata severity index
Timepoint
The beginning of the study, one month, two months, three months, six months after the start of the study.
Method of measurement
Viewing Dermoscopy criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a vial of methotrexate containing 25 mg/ml is used. After septic procedures, methotrexate is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.02 ml per site. A maximum of 0.1-0.2 ml (2.5-5 mg) is injected per session using a 0.5 inch length. A 30 mm needle connected to an insulin syringe will be used.
Category
Treatment - Drugs
2
Description
Control group: The amount of intralesional steroids used is 40 mg/ml. One-fifth diluted triamcinolone acetonide (8 mg/ml) is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.05-0.1 ml per site. A maximum of 2 ml (20 mg) is injected per session using a length of 0.5 inches. A 30 mm needle connected to an insulin syringe will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diphencyprone Clinic- Razi Dermatology Hospital
Full name of responsible person
Doctor Narges Ghandi
Street address
Razi Blind Alley, Vahdate-Islami Square, Vahdate-Islami Street, Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research and Technology,Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr.Akbar fotuhi
Street address
Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 9271
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research and Technology,Tehran University of Medical Sciences and Health Services