SOOTHER Trial to Treat Rectal Itch

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

Completed

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Key information

Conditions

Pruritus Ani Anus Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pruritus Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Minnesota Gastroenterology

Plymouth, Minnesota, 55466, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine Ointment

Drug

Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks.

Primary outcomes

Symptom assessment

Time frame: 2 weeks

SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst
Visual ano-rectal exam

Time frame: 2 weeks

Visual ano-rectal exam assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst.

Sponsors and collaborators

Lead sponsor

Bell International Laboratories

Industry

Registry information

Official study title

SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2021
First posted: Mar 21, 2022
Registry last updated: Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed