Protocol summary

Study aim
Comparative study of the effectiveness of fractional CO2 laser with topical triamcinolone acetonide versus intralesional triamcinolone acetonide injection in the treatment of patients with alopecia areata referred to Razi Hospital
Design
A randomized, single-blind, parallel-group, controlled clinical trial was conducted based on randomized blocks on 35 patients with alopecia areata.
Settings and conduct
Razi Hospital, Allopath Patch Patients are randomly divided into two groups A and B: Group A: Treated with CO2 laser plus topical triamcinolone acetonide cream Group B: Treated with intradermal triamcinolone acetonide injection Both groups received 4 sessions of treatment at 4-week intervals. Treatment efficacy was assessed by SALT score, dermoscopy, and VAS/VDS scales. Alopecia areata predictive score was measured according to dermoscopic criteria. Adverse events collected from both treatments were assessed by a dermatologist who was blinded to the treatment method performed on each patch (evaluator).Also, side effects and patient satisfaction are recorded.
Participants/Inclusion and exclusion criteria
Patients with alopecia areata(AA) over 15 years of age who have at least 2 or more comparable, anatomically similar, symmetrical alopecia patches on both sides of the head, at least 2 cm apart, and SALT less than 25%, and who have not received systemic medication or intralesional injection effective for alopecia areata in the last 2 months, will be included in the study.Also, patients with systemic diseases, immunocompromised patients, and pregnant patients were excluded from the study.
Intervention groups
Treatment (A, i.e. laser + topical triamcinolone) and treatment (B, i.e. local injection of triamcinolone with a needle) are used randomly in the right or left allopic patch for each patient.
Main outcome variables
Increase Severity of Alopecia Tool score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251003067487N1
Registration date: 2025-10-12, 1404/07/20
Registration timing: registered_while_recruiting

Last update: 2025-10-12, 1404/07/20
Update count: 0
Registration date
2025-10-12, 1404/07/20
Registrant information
Name
Bahar Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5288 8282
Email address
baharsadeghi045@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-10-12, 1404/07/20
Expected recruitment end date
2026-10-12, 1405/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effectiveness of fractional CO2 laser with topical triamcinolone acetonide versus intralesional triamcinolone acetonide injection in the treatment of patients with alopecia areata
Public title
Studying the effect of fractional CO2 laser in the treatment of alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with alopecia areata over 15 years of age Have at least 2 or more comparable, anatomically similar, symmetrical allopathic patches on both sides of the head at least 2 cm apart. Alopecia severity scoring system is less than 25%. They have not received systemic medication or intralesional injection effective for alopecia areata in the last 2 months.
Exclusion criteria:
Immunocompromised patients Pregnant patients Patients with systemic diseases - cardiac, renal and hepatic disorders
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 35
More than 1 sample in each individual
Number of samples in each individual: 2
The right or left patch of alopecia areata will receive the indicated treatments based on randomization.
Randomization (investigator's opinion)
Randomized
Randomization description
The study method is a clinical trial, patients receive the desired treatment using the randomization method in the form of a random list, which is explained below. For this purpose, we assign an English letter to each of the treatment methods, which in this study, since two types of treatment are examined, treatment (A, i.e. co2 laser) and treatment (B, i.e. local injection of triamcinolone with a needle) are used.Treatment (A, i.e. microneedle) and treatment (B, i.e. local injection of triamcinolone with a needle) are used. On the other hand, since each patient receives both treatments and statistical methods have more power with equal volume in each treatment group, in order to obtain equal sample size for each treatment method, we proceed as follows: we define two drug combinations AB and BA.The AB combination means that treatment A will be injected for the person's right side and treatment B for the person's left side. Similarly, the BA combination means that treatment B will be injected for the person's right side and treatment A for the person's left side.Next, to prepare the random list, a random number table is used in such a way that a random number from 0 to 9 is generated for each patient. If the generated number is between 0 and 4, the AB combination is considered, and if the selected number is between 5 and 9, the BA combination is considered. To prepare the random list, the Random Allocation Software will be used, the output of which is reported below.
Blinding (investigator's opinion)
Single blinded
Blinding description
The randomized, parallel-group clinical trial was designed as a single-blind study. Thus, each alopecia patch was assigned to only one of the two intervention or control groups. In order to maintain blinding, the interventions in the two groups were made similar in terms of appearance, method of administration, and visit schedule.Randomization codes were generated by an independent researcher and stored in sealed envelopes. The outcome assessor was also unaware of the allocation of patients to treatment groups, and the grouping codes were only revealed after data collection was completed and the database was locked. This blinding method minimized the possibility of bias in the assessment of intervention effectiveness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee,Tehran University of Medical Sciences
Street address
6th Floor, Room 604, Central Building, Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2025-07-07, 1404/04/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.244

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
Timepoint
Before the intervention begins - at each session - one month after the end of treatment
Method of measurement
As observed by a dermatologist and scored according to the relevant system/Scoring is based on clinical and dermoscopy photographs.

2

Description
Pain
Timepoint
After each treatment session
Method of measurement
Visual discomfort scale (VDS)

3

Description
Patient satisfaction with hair growth
Timepoint
After each treatment session
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Alopecia patches are mapped on a transparent sheet and a graph paper to calculate the area of ​​each patch in square centimeters. In the control patch, intralesional injection treatment of triamcinolone at the same dose (10 mg/mL) is used at a dose of 0.1 mL/cm2.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group: Topical anesthetic cream Xyla P (lidocaine + prilocaine) was applied to the site 45 minutes before the laser and after achieving satisfactory local anesthesia, the treated area was cleaned with a gauze soaked in distilled water. The eyes were protected with a shield and the CO2 laser was used with the following settings:As a pilot, with a density of 120-144/energy of 10, 2 minutes after laser treatment, topical triamcinolone acetonide solution is applied to the site, based on the measured area of ​​the lesion, at a rate of 0.05 cc per square centimeter. Patients in this group receive the aforementioned treatment in 4 sessions at 4-week intervals.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Narges ghandi
Street address
Razi Dermatology Hospital, Vahdat-e Eslami Street
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5561 8989
Email
Nghandi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Tehran University of Medical Sciences, 16th Azar Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 8898 9487
Email
Nghandi@tums.ac.ir
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
Narges ghandi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Dermatology Hospital, Vahdate Eslami street
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5561 8989
Email
Nghandi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges ghandi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Dermatology Hospital, Vahdate Eslami street
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5561 8989
Email
Nghandi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges ghandi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Dermatology Hospital, Vahdate Eslami street
City
Tehran
Province
Tehran
Postal code
۱۱۹۹۶۶۳۹۱۱
Phone
+98 21 5561 8989
Email
Nghandi@tums.ac.ir

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
after making the data unidentifiable, it would be publishable.
When the data will become available and for how long
3 months after publishing the article
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
those who send emails to the corresponding author.
From where data/document is obtainable
To receive the documentation of this research, please submit your request to the email address of Dr. Narges Ghandi (corresponding author) at Nghandi@tums.ac.ir.
What processes are involved for a request to access data/document
Send an email to the author responsible for the study, documents, and data within two weeks to a maximum of one month from the date of submitting the request. The data will be sent in Excel format and, if requested, clinical photographs of the patients.
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