DermatitisNCT03073837
Rudolph: Nasal Microbiota With Red and Sore Nose
A study testing Rhinovirus Challenge in people with Dermatitis, run by Kimberly-Clark Corporation at 1 site in Netherlands.
Trial summary
This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis
- What is being tested?
- Rhinovirus Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2017to 15 Aug 2017
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- self reported proneness to developing symptoms of nose redness and/or soreness
- sero-negative to HRV-16 at screening
Who cannot join
- confirmed or self-reported allergic rhinitis
- history of nasal or otologic surgery
- use of anti-inflammatory medication, recent antibiotics or anti-histamines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects
This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.
- Conditions
- Dermatitis
- Being tested
- Rhinovirus Challenge
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinovirus ChallengeOther
Challenge with HRV-16 virus
| Study group | Role | What they receive |
|---|---|---|
| Rhinovirus Challenge | Other | Challenge with HRV-16 Receives: Other: Rhinovirus Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating >37mm
Measured: change from baseline compared to day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start20 Mar 2017
- Primary completion18 Apr 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor
- Investigators
- Lutter Rene, PhD, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073837
- Sponsor's protocol ID
- 500-16-0006
- Status last verified
- Aug 2017
- First submitted
- 21 Feb 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03073837
- Acronym / sponsor ID
- 500-16-0006
- Conditions
- Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 8 Mar 2017 (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.
This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhinovirus Challenge | Other | Other: Rhinovirus ChallengeChallenge with HRV-16 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- self reported proneness to developing symptoms of nose redness and/or soreness
- sero-negative to HRV-16 at screening
Key exclusion criteria (3 listed)
- confirmed or self-reported allergic rhinitis
- history of nasal or otologic surgery
- use of anti-inflammatory medication, recent antibiotics or anti-histamines
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 |
|---|---|---|
| Rhinovirus ChallengeChallenge with HRV-16 virus | Other | Rhinovirus Challenge |
Primary outcome
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Time frame: change from baseline compared to day 22
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating >37mm
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 18 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Lutter Rene, PhD principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinovirus Challenge in people with Dermatitis, run by Kimberly-Clark Corporation at 1 site in Netherlands.
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 2 inclusion and 3 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 18 Aug 2017. 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 Netherlands. 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?
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection (time frame: change from baseline compared to day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.