Status:
COMPLETED
SOOTHER Trial to Treat Rectal Itch
Lead Sponsor:
Bell International Laboratories
Conditions:
Pruritus Ani
Eligibility:
All Genders
18-80 years
Brief Summary
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)
Eligibility Criteria
Inclusion
- Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.
Exclusion
- Inability to understand informed consent, history of inflammatory bowel disease, known venereal disease, or immunodeficiency disease, history of or current anal or perianal abscess, anal or rectal surgery within the past 12 weeks, pregnancy or breastfeeding female, or signs of other rectal diseases such as anorectal fistula, infection, perianal eczema or tumors.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05288907
Start Date
September 1 2018
End Date
December 10 2021
Last Update
July 22 2022
Active Locations (1)
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1
Minnesota Gastroenterology
Plymouth, Minnesota, United States, 55466