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IRCT20250228064873N3 IRCT 2025-10-04 Tehran University of Medical Sciences evaluation of efficacy and safety of microneedle skin patch carrying triamcinolone in the treatment of alopecia areata compared to local injection of triamcinolone with a needle A single-blind clinical trial pilot study of the efficacy and safety of microneedle skin patch carrying triamcinolone in the treatment of alopecia areata compared to local injection of triamcinolone with a needle 2025-10-23 anticipated 10 Recruiting https://irct.ir/trial/85876 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. microneedle) 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 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: Alopecia patches are mapped on a transparent sheet and a graph paper to calculate the area of ​​each patch in square centimeters.In this group, patients undergo microneedling with topical triamcinolone injection. The total calculated dose is divided into two equal parts to be used before and after microneedling. After application, the patient is asked not to wash the treated area for the next few hours. 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: academic researchers and industrial workers. 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. Ifa Etesami (responsible author) at ifa.etesami@gmail.com. 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 Ifa Etesami
Razi Dermatology Hospital, Vahdate Eslami street
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 Ifa.etesami@gmail.com Tehran University of Medical Sciences scientific Ifa Etesami
Razi Dermatology Hospital, Vahdate Eslami street
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 ifa.etesami@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Alopecia areata patient over 18 years of age with independent clinical diagnosis by a dermatologist At least two patches that do not require systemic treatment Alopecia areata limited to the scalp SALT SCORe less than 20% limited to the scalp 18 years no limit Both Patients who have previously been treated for alopecia areata within the past 12 weeks Have any autoimmune or systemic disease 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: Alopecia patches are mapped on a transparent sheet and a graph paper to calculate the area of ​​each patch in square centimeters.In this group, patients undergo microneedling with topical triamcinolone injection. The total calculated dose is divided into two equal parts to be used before and after microneedling. After application, the patient is asked not to wash the treated area for the next few hours. Severity of ALopecia Tool (SALT) Score. Timepoint: Individuals are followed up monthly for up to three months. Before the intervention begins, 1-2-3 months after the intervention. 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 Analogue Scale(VAS). Tehran University of Medical Sciences Approved 2025-03-25 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, Iran tehran Tehran Iran (Islamic Republic of)