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Clinical Trials/NCT03073837
NCT03073837
Completed
Not Applicable

RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects

Kimberly-Clark Corporation1 site in 1 country10 target enrollmentMarch 20, 2017
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ConditionsDermatitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dermatitis
Sponsor
Kimberly-Clark Corporation
Enrollment
10
Locations
1
Primary Endpoint
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 20, 2017
End Date
August 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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