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

Evaluation of the efficacy and safety of a microneedle skin patch containing triamcinolone in reducing the volume of alopecia areata and comparing its efficacy with conventional needle injections in patients diagnosed with alopecia areata referred to Razi Skin Hospital.

A randomized, single-blind, parallel-group, controlled clinical trial was conducted based on randomized blocks on 10 patients with alopecia areata.

At Razi Hospital, at the end of the patient collection, the patient's photos are reviewed and scored for hair growth by a dermatologist who is unaware of the treatment method performed on each patch (the evaluator). The evaluator does not know what treatment each patient received. Patients with AA over 18 years of age with a clinical diagnosis and meeting the inclusion criteria for AA limited to the scalp. Treatment (A, i.e. microneedle) and treatment (B, i.e. local injection of triamcinolone with a needle) are used randomly in the right or left allotopic patch for each patient.

Alopecia areata(AA) patients over 18 years of age with independent clinical diagnosis by a dermatologist and meeting the AA entry criteria of limited scalp AA of less than 20% limited to the scalp and at least two patches that do not require systemic treatment are selected.Patients who had previously been treated for AA within the past 12 weeks or had any autoimmune or systemic disease were excluded from the study.

Treatment (A, i.e. microneedle) and treatment (B, i.e. local injection of triamcinolone with a needle) are used randomly in the right or left allotopic patch for each patient.

Increase Severity of Alopecia Tool score

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.

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.

after making the data unidentifiable, it would be publishable.

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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.

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.