SOOTHER Trial to Treat Rectal Itch

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05288907

Enrollment

Registered

2022-03-21

Start date

2018-09-01

Completion date

2021-12-10

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus Ani

Keywords

Pruritus ani, rectal itch, anal itch

Brief summary

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

Interventions

DRUGLidocaine Ointment

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026