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

JRCT ID: jRCTs061210021

Registered date:08/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Severe dermal pain caused by sweating stimuli of heat stress
• Date of first enrollment: 01/12/2021
• Target sample size: 10
• Study type: Interventional
• 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 Outcome: The 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 Outcome

Secondary 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
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Takahagi Shunsuke
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development