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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210021

Registered date:08/07/2021

A study on the efficacy of icatibant for sweating-induced dermal pain

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedSevere dermal pain caused by sweating stimuli of heat stress
Date of first enrollment08/07/2021
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)Subcutaneous injection of 30 mg (3 mL) of bradykinin B2 receptor antagonist icatibant or 3 mL of saline solution as a placebo once daily.Thermal stimulation is applied before and after administration of icatibant or placebo.

Outcome(s)

Primary OutcomeThe primary endpoint was the amount of change in the Visual analogue scale (VAS) score of dermal pain induced by heat stimuli before and after administration of icatibant or placebo.
Secondary OutcomeSecondary outcomes include the amount of change in the duration of skin pain induced by termal stimuli before and after administration of icatibant or placebo. Blood samples will be collected before and after administration of icatibant or placebo to measure histamine in plasma and whole blood, and serum angiotensin-converting enzyme (ACE). Skin sample will be collected prior to administration of icatibant or placebo to histologically assess the pathogenesis of skin pain. Alternatively, if a skin biopsy has been performed in the previous practice, existing specimens were examined.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 50age old
GenderBoth
Include criteria1 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.
Exclude criteria1. 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.

Related Information

Contact

Public contact
Name Shunsuke Takahagi
Address 1-2-3, Kasumi, Minami-ku, Hiroshima 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5238
E-mail shunstk@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Shunsuke Takahagi
Address 1-2-3, Kasumi, Minami-ku, Hiroshima 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5238
E-mail shunstk@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital