SOOTHER Trial to Treat Rectal Itch

Completed

Conditions studied: Pruritus Ani

In brief

Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)

Key facts

Study ID

NCT05288907

Run by

Bell International Laboratories

People needed

20

Starts

2018-09-01

Expected to finish

2021-12-10

Last updated by the study team

2022-07-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.

You may not qualify if…

• 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.

Where it is running

• Minnesota Gastroenterology — Plymouth, Minnesota, United States

Full record on ClinicalTrials.gov

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