comparison of the effect of combined intralesional Triamcinolone with topical Bimatoprost versus intralesional Triamcinolone or topical Bimatoprost in the treatment of alopecia areata
Determination and comparison of the improvement of alopecia areata lesion site based on PGA score, SALT score, and dermoscopic findings in the three studied groups, controlling for the possible effect of age, gender, and lesion site.
Design
3 parallel-group, single-blind, randomized, phase 3 clinical trial on 42 patients. A sealed envelope site was used for randomization.
Settings and conduct
This study includes 48 patients with alopecia areata referred to the clinic of Imam Khomeini Hospital. Evaluation of lesions by dermoscopy and photography will be performed before the start of treatment and one month after the last stage of treatment. It is single-blind, meaning that the physician evaluating the results will be unaware of the treatment method used.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age who have at least one patch of alopecia areata and have not received treatment in the last three months and do not have any contraindications to treatment such as pregnancy, breastfeeding, and local allergy or infection.
Intervention groups
The first group will be treated with intralesional triamcinolone injection (5mg/ml for scalp alopecia and 2.5mg/ml for facial alopecia), the second group will be treated with bimatoprost 0.01% every 12 hours, and the third group will be treated with a combination of monthly triamcinolone injection and topical bimatoprost.
Main outcome variables
Age; Gender; Lesion site improvement based on Physician Assessment System (PGA) score; Patient satisfaction; Dermoscopy findings; SALT scoring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251014067632N1
Registration date:2026-04-28, 1405/02/08
Registration timing:registered_while_recruiting
Last update:2026-04-28, 1405/02/08
Update count:0
Registration date
2026-04-28, 1405/02/08
Registrant information
Name
Negin Soozangar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1837
Email address
negin.sgr@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-02-03, 1404/11/14
Expected recruitment end date
2026-07-05, 1405/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of combined intralesional Triamcinolone with topical Bimatoprost versus intralesional Triamcinolone or topical Bimatoprost in the treatment of alopecia areata
Public title
effect of bimatoprost on alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years of age with the hair loss pattern of alopecia areata who have at least one or more patches of alopecia.
Consent to participate in the study.
Exclusion criteria:
Sensitivity to the medications used.
Pregnancy and breastfeeding.
Systemic treatment has been performed within the past 3 months or topical treatment has been performed within the past 2 weeks.
The site of application of the medicine is infected.
Patients with pattern universalis or ophiasis or totalis
Patients with spontaneous hair regrowth in the area of hair loss
Patients with other dermatological diseases simultaneously
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Using the randomization method, patients are divided into three groups. A sealed envelope site is used to divide patients, and randomization is performed in blocks, and each block consists of 6 patients and includes 2 groups A, 2 groups B, and 2 groups C. In order to eliminate the effect of the interpretation of the researcher and the performing physician, in addition to observing blinding, the technique of concealing the allocation of numbers and letters was used, and the names of the groups were hidden.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician evaluating the results will be unaware of the treatment method used. At the beginning of treatment and one month after the last session, photographs of the lesions will be taken using a Xiaomi Redmi note11 pro mobile phone at a distance of 30 cm.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No.2004, Unit 10, 5th Floor, Asadi8 Complex, 48 Daneshjoo St., daneshgah Town
City
ahwaz
Province
Khouzestan
Postal code
6134933357
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
IR.AJUMS.REC.1404.303
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
amount of change in the SALT score (from 0 to 100).
Timepoint
At the beginning of treatment and one month after the end of treatment
Method of measurement
According to the areas involved in the scalp /left side:18% , right side=18%)/ ,top=40%,back=24 / (S0=no hair loss/ s1=<25% hair loss/ s2= 25%-49% hair loss/ s3=50%-74% hair loss/ s4=75-99%hairloss/ s5=100% total scalp hair loss)
2
Description
Changes in dermoscopy findings
Timepoint
At the beginning of treatment and one month after the end of treatment
Method of measurement
Based on the researcher's observation (determining the number of black dots, yellow dots, broken hairs, exclamation mark hairs, villous hairs)
3
Description
Checking the rate of change in GPA score
Timepoint
At the beginning of treatment and one month after the end of treatment
Method of measurement
Evaluation of patient outcomes by a physician outside the study based on the response rate to treatment using photographs taken before and one month after treatment (from 0 to 4) (A0 = no improvement / A1 = poor response <25% / A2 = good response 25 to 50% / A3 = very good response 50 to 75% / A4 = excellent response 75 to 100%)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: was treated with intralesional triamcinolone injection (5mg/ml for scalp alopecia and 2.5mg/ml for facial alopecia) monthly for three months.
Category
Treatment - Drugs
2
Description
Intervention group:Under treatment with bimatoprost 0.01% every 12 hours for three months
Category
Treatment - Drugs
3
Description
Intervention group: Under combination treatment of monthly triamcinolone injections and topical bimatoprost every 12 hours for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Tara Barat
Street address
Imam Khomeini hospital, azadegan st.
City
ahwaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3292 1837
Email
negin.sgr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr.abdollah rafeai
Street address
Ahvaz Jundishapur University, North Esfand Street, Golestan Alley
City
ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Web page address
https://vchresearch.ajums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Research data, including anonymized consent forms and before-and-after photos of patients' results, along with basic information including gender and age, will be shared.
When the data will become available and for how long
Access begins 6 months after publication of the article.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
To conduct further studies in this field or other parallel and related studies.
From where data/document is obtainable
To receive the documents, please send a request to Dr. Negin Sozengar's email: negin.sgr@gmail.com. If there is no response, please send a request to the address: Dermatology Department Office, 3rd Floor, Imam Hospital, Azadegan Street, Ahvaz, Khuzestan.
What processes are involved for a request to access data/document
After registering the request in writing, along with the phone number and details of the applicant, to the email or address mentioned, a response will be received within one week after the necessary checks.
The reason for requesting the documents should also be mentioned.