SOOTHER Trial to Treat Rectal Itch

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-10

Brief Summary

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

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Detailed Description

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Conditions

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Pruritus Ani

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pruritus ani patients

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

Lidocaine Ointment

Intervention Type DRUG

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

Interventions

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Lidocaine Ointment

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No