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

Phase 2

• Conditions: Severe dermal pain caused by sweating stimuli of heat stress; dermal pain, perspiration

• Registration Number: JPRN-jRCTs061210021
• Lead Sponsor: Takahagi Shunsuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-08
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified