Pruritus AniNCT05288907
SOOTHER Trial to Treat Rectal Itch
An observational study of Pruritus Ani, run by Bell International Laboratories at 1 site in United States.
Trial summary
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pruritus Ani
- What is being tested?
- Lidocaine Ointment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with pruritus ani (anal itch/discomfort)
Who may be able to join
- Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Gastroenterology
Plymouth, Minnesota, 55466
About this study
Official title: SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)
- Conditions
- Pruritus Ani
- Being tested
- Lidocaine Ointment
- Keywords
- Pruritus ani, rectal itch, anal itch
- Medical subject headings
- Pruritus Ani
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine OintmentDrug
Composite over-the-counter lidocaine ointment administered twice daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pruritus ani patients | Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment Receives: Drug: Lidocaine Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom assessment
SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Sep 2018
- Primary completion13 Aug 2019
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pruritus AniStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bell International Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammad Saremi, Principal investigator, Bell International Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288907
- Sponsor's protocol ID
- 20181914
- Status last verified
- Jul 2022
- First submitted
- 11 Mar 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36186810
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch
- ClinicalTrials.gov ID
- NCT05288907
- Acronym / sponsor ID
- 20181914
- Conditions
- Pruritus Ani
- Keywords
- Pruritus ani, rectal itch, anal itch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bell International LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pruritus ani patients | – | Drug: Lidocaine OintmentAdult patients with pruritus ani (rectal itch) treated with lidocaine ointment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pruritus ani (anal itch/discomfort)
Key inclusion criteria (1 listed)
- Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine OintmentComposite over-the-counter lidocaine ointment administered twice daily for 2 weeks. | Drug | Pruritus ani patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 36186810Felemovicius 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Saremi principal investigator
Bell International Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pruritus Ani, run by Bell International Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom assessment (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.