SOOTHER Trial to Treat Rectal Itch

Bell International Laboratories

Status: Completed

Conditions: Pruritus Ani

Treatments: Drug: Lidocaine Ointment

Study type: Observational

Funder types: Industry

Identifiers

NCT05288907

20181914

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

20 participants in 1 patient group

Pruritus ani patients

Description:

Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment

Treatment:

Drug: Lidocaine Ointment