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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pruritus ani patients | Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Ointment | Drug | Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom assessment | SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst | 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with pruritus ani (anal itch/discomfort)
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Saremi | Bell International Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Gastroenterology | Plymouth | Minnesota | 55466 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36186810 | Derived | Felemovicius I, Ganz RA, Saremi M, Christopfel W. SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch. Front Med (Lausanne). 2022 Sep 14;9:890883. doi: 10.3389/fmed.2022.890883. eCollection 2022. |
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| ID | Term |
|---|---|
| D011538 | Pruritus Ani |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 |
| Digestive System Diseases |
| D011537 | Pruritus |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |