A single-blind, randomized, crossover study on the efficacy of icatibant for sweating-induced dermal pain. - Icatibant for sweating-induced dermal pain

Takahagi Shunsuke0 个研究点目标入组 10 人开始时间: 2021年7月8日最近更新: 2024年5月27日

试验速览

暂无简介。

•1 Male and female between 18 and 50 years of age at the time of obtaining consent.
•2 Patients with severe dermal pain caused by sweating stimuli of heat stress (bathing, etc.).
•3. Dermal pain continues for more than 3 months.
•4. VAS score of dermal pain is 40 mm or more during the 2 weeks prior to obtaining consent.
•5. Patients who have not changed their medication* with the potential to alleviate symptoms within 2 weeks prior to obtaining consent and have no plans to change it until the end of the study (including injection, oral or topical medication). *Antihistamines, H2 antagonists, antileukotrienes, systemic corticosteroids, immunosuppressants, antipyretic analgesics, narcotics, psychotropic drugs, and drugs that affect the central and peripheral nervous system.
•6. Patients with written consent to participate in this study.

•1. Patients with other causes of dermal pain.
•2. Patients with atopic dermatitis, Sjogren's syndrome, hypothyroidism, Fabry disease, autonomic disorders, or drug-induced anhidrosis. To rule out these diseases, SS-A antibody, SS-B antibody, FT3, FT4, and TSH are measured. In cases where pain in the hand and foot regardless of sweating conditions or abnormal sweating appears by school age, alpha-galactosidase activity is measured and, in female ceses, genetic testing is performed as needed. Cases with abnoromal results are excluded.
•3. Patients with hypersensitivity to Icatibant.
•4. Pregnant or lactating women.
•5. Patients with skin ulcer or sensory disturbance on their lower limbs.
•6. Patients taking angiotensin-converting enzyme inhibitors.
•7. Patients who are judged by the principal investigator or sub-investigator to be medically inappropriate for the administration of the study drug or who are judged to have a condition which affects results of the study.

发起方

Takahagi Shunsuke