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IRCT20251003067487N1 IRCT 2025-10-12 Tehran University of Medical Sciences Studying the effect of fractional CO2 laser in the treatment of alopecia areata 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 2025-10-12 anticipated 35 Recruiting https://irct.ir/trial/86650 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Alopecia Areata. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: after making the data unidentifiable, it would be publishable. When: 3 months after publishing the article To whom: It will be available to researchers working in academic and scientific institutions. Conditions: those who send emails to the corresponding author. Where to obtain: 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. How to obtain: 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. Comments:
public Narges ghandi
Razi Dermatology Hospital, Vahdate Eslami street
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 Nghandi@tums.ac.ir Tehran University of Medical Sciences scientific Narges ghandi
Razi Dermatology Hospital, Vahdate Eslami street
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 Nghandi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 15 years no limit Both Immunocompromised patients Pregnant patients Patients with systemic diseases - cardiac, renal and hepatic disorders L63 Alopecia areata Treatment - Drugs Treatment - Drugs 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. 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. 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. Pain. Timepoint: After each treatment session. Method of measurement: Visual discomfort scale (VDS). Patient satisfaction with hair growth. Timepoint: After each treatment session. Method of measurement: Visual analogue scale (VAS). Tehran University of Medical Sciences Approved 2025-07-07 Research Ethics Committee,Tehran University of Medical Sciences 6th Floor, Room 604, Central Building, Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)