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CompletedNCT03073837Updated Aug 18, 2017

Rudolph: Nasal Microbiota With Red and Sore Nose

An interventional study of Rhinovirus Challenge in Dermatitis, sponsored by Kimberly-Clark Corporation. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.

Sponsored by Kimberly-Clark Corporation · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.

02

Conditions studied

  • Dermatitis

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03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 10 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Kimberly-Clark Corporation is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • self reported proneness to developing symptoms of nose redness and/or soreness
  • sero-negative to HRV-16 at screening

Exclusion criteria

Exclusion Criteria:

  • confirmed or self-reported allergic rhinitis
  • history of nasal or otologic surgery
  • use of anti-inflammatory medication, recent antibiotics or anti-histamines
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    Rhinovirus Challenge

    Challenge with HRV-16

    Other: Rhinovirus Challenge

Interventions

  • OtherRhinovirus Challenge

    Challenge with HRV-16 virus

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: change from baseline compared to day 22

07

Study locations

1 site
  • Academic Medical Center
    Amsterdam, 1105AZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03073837
Lead sponsor
Kimberly-Clark Corporation
Collaborators
NIZO Food Research, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Sponsor
First posted
Mar 8, 2017
Start date
Mar 20, 2017
Primary completion
Apr 18, 2017
Completion
Aug 15, 2017
Last update
Aug 18, 2017

Study contacts

Lutter Rene, PhD
principal investigator · AIDS Malignancy Consortium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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