NCT03073837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

29 days

First QC Date

February 21, 2017

Last Update Submit

August 15, 2017

Conditions

Dermatitis

Outcome Measures

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

    change from baseline compared to day 22

Study Arms (1)

Rhinovirus Challenge

OTHER

Challenge with HRV-16

Other: Rhinovirus Challenge

Interventions

Rhinovirus ChallengeOTHER

Challenge with HRV-16 virus

Rhinovirus Challenge

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lutter Rene, PhD

    AIDS Malignancy Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 8, 2017

Study Start

March 20, 2017

Primary Completion

April 18, 2017

Study Completion

August 15, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)