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Completed

NCT Number: NCT03073837

Rudolph: Nasal Microbiota With Red and Sore Nose

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

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Key information

Conditions

Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhinovirus Challenge

Other

Challenge with HRV-16 virus

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • NIZO Food Research

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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