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NCT03073837 Clinical Trial

Rudolph: Nasal Microbiota With Red and Sore Nose

Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03073837
Other study ID # 500-16-0006
Secondary ID
Status Completed
Phase N/A
First received February 21, 2017
Last updated August 15, 2017
Start date March 20, 2017
Est. completion date August 15, 2017

Study information
Verified date August 2017
Source Kimberly-Clark Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 15, 2017
Est. primary completion date April 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Rhinovirus Challenge
Challenge with HRV-16 virus

Locations
Country Name City State
Netherlands Academic Medical Center Amsterdam

Sponsors (3)
Lead Sponsor Collaborator
Kimberly-Clark Corporation Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), NIZO Food Research

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 change from baseline compared to day 22
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