Microneedle transdermal delivery of compound betamethasone in alopecia areata—A randomized controlled trial - 06/11/24

Doi : 10.1016/j.jaad.2024.09.059

Rui Qiao, MD, Jiaping Zhu, MD, Jing Fang, MD, Hualing Shi, MD, Ziye Zhang, MD, Jin Nie, MD, Yiping Ge, MD ^⁎ , Tong Lin, MD ^⁎ , Yiqun Jiang, MD ^⁎
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China

^∗Correspondence to: Yiqun Jiang, MD, Tong Lin, MD, and Yiping Ge, MD, Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, 12 Jiangwangmiao St, Nanjing, Jiangsu 210042, China.Hospital for Skin DiseasesInstitute of DermatologyChinese Academy of Medical Sciences & Peking Union Medical College12 Jiangwangmiao StNanjingJiangsu210042China

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Wednesday 06 November 2024

Abstract

Background

Alopecia areata (AA) places a considerable burden on patients. While intralesional glucocorticoid injection is an important therapy, it can cause severe pain.

Objective

To compare the efficacy and pain levels of microneedle transdermal delivery of compound betamethasone versus traditional intralesional injection in mild-to-moderate AA.

Methods

We conducted a randomized controlled trial in AA patients with a Severity of Alopecia Tool (SALT) score <50. Both groups received monthly compound betamethasone injections: group A via intralesional injections and group B via transdermal microneedle delivery. The primary outcome was the reduction in SALT score after 3 months.

Results

With 80 patients enrolled, baseline SALT scores were similar between group A (9.250 ± 5.300) and group B (10.65 ± 9.445). After 3 months, the mean SALT reduction was 7.000 ± 4.5017 in group A and 8.075 ± 8.014 in group B, with no statistical difference. Remission rates for SALT30/50/75/90 were 92.50/90.00/57.50/42.50% in group A and 95.00/87.50/72.50/40% in group B, with no significant difference. Group B had a significantly lower visual analog scale pain score than group A (4.000 ± 1.174 vs 5.281 ± 2.098, P = .0047).

Limitations

The study focused on mild-to-moderate patchy AA, limiting insights into severe cases.

Conclusion

Microneedle transdermal delivery of compound betamethasone in mild-to-moderate patchy AA demonstrates efficacy comparable to traditional intralesional injection with reduced pain.

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Key words : alopecia areata, betamethasone, glucocorticosteroids, intralesional injection, microneedles, randomized controlled trial, transdermal delivery

Abbreviations used : AA, CCL, DLQI, DPCP, IFN, IL, JAK, NKG2D, PDE4, PRO, SALT, SD, VAS, VD3

Plan

Introduction

Methods

Study design

Sample size calculation

Inclusion criteria

Exclusion criteria

Recruitment and allocation

Study procedures

Outcome measures

Safety and adverse events evaluation

Statistical analysis

Results

Completion rates comparison and baseline assessment

	Drs Qiao and Zhu contributed equally to this work and are cofirst authors.
	Drs Jiang, Lin, and Ge contributed equally to this work and are cocorresponding authors.
	Funding sources: This work was supported by CAMS Innovation Fund for Medical Sciences (CIFMS-2021-I2M-1-001) and Key Project of Social Development in Jiangsu Province (BE2023676).
	Patient consent: This study is a clinical trial. The investigators provided all enrolled patients with a full explanation of the potential benefits and risks of participation, and informed consent was obtained from each participant.
	IRB approval status: The study design adhered to the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College (approval number 2021-KY-019).
	Data availability: If there are valid reasons for requesting the data generated during the research or the study protocol, such information can be obtained by contacting the corresponding author.