SOOTHER Trial to Treat Rectal Itch

Bell International Laboratories20 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pruritus Ani

Interventions

Lidocaine OintmentDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Minnesota Gastroenterology

Plymouth, Minnesota, United States

Outcomes

Primary Outcomes

Symptom assessment

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

Time frame: 2 weeks

Visual ano-rectal exam

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.