Rudolph: Nasal Microbiota With Red and Sore Nose

Not Applicable

Completed

• Conditions: Dermatitis
• Interventions: Other: Rhinovirus Challenge

• Registration Number: NCT03073837
• Lead Sponsor: Kimberly-Clark Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2017-03-20
• Primary Completion: 2017-04-18
• Status Verified: 2017-08
• Study Completion: 2017-08-15
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rhinovirus Challenge	Rhinovirus Challenge	Challenge with HRV-16

Primary Outcome Measures

Name	Time	Method
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection	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

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands