NCT00993759

Brief Summary

The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses. The study will also evaluate the safety of 3804-250A.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

October 8, 2009

Last Update Submit

October 9, 2009

Conditions

Common ColdHealthy

Keywords

common coldrhinovirusprevention

Outcome Measures

Primary Outcomes (1)

  • Reduction of rhinovirus-induced common colds.

    9 weeks

Secondary Outcomes (1)

  • Reduction of rhinovirus infections and reduction of common colds.

    9 weeks

Study Arms (2)

No treatment

NO INTERVENTION

3804-250A lotion

EXPERIMENTAL
Drug: 3804-250A

Interventions

3804-250ADRUG

3.2 ml applied topically after hand washing and at least every 3 hours while awake.

3804-250A lotion

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Read and sign a copy of the approved Consent Form;
  • years of age;
  • If a woman of child bearing potential (WOCBP) must have a negative urine pregnancy test and be using an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, vasectomized partner, abstinence, or condoms;
  • Capable of compliance with the required study and sick visits (i.e., no planned travel commitments);
  • Willing to follow study restrictions;
  • Generally in good health based on medical history interview.

You may not qualify if:

  • Current participation on any study;
  • Participation in an investigational drug study within 30 days of enrollment;
  • Participation within 30 days of enrollment on any study where the hands were the test site;
  • Pregnancy (as determined by an urine pregnancy test), lactation or planning a pregnancy during the course of the study;
  • Daily smoker;
  • Current or significant history of sinusitis;
  • Skin conditions on the hands or wrists that would interfere with the evaluations, such as scars, tattoos, uneven skin tones, or other conditions;
  • Allergy to soaps, detergents, preservatives, citric acid, malic acid or ethanol;
  • Immunological disorders (i.e., AIDS, HIV, systemic lupus erythematosis, rheumatoid arthritis);
  • Current use or use within 7 days prior to randomization of any antibacterial medications for treatment of respiratory infections;
  • Current use or use within 7 days enrollment of topical drugs (e.g. hydrocortisone or other corticosteroids) to treat skin conditions on the hands or wrists, except for localized treatment of minor cuts or scrapes;
  • Occupational or other requirement for unusually frequent hand washing (i.e. health care worker, food service worker);
  • Currently suffering from respiratory allergies or a history of seasonal respiratory allergies that are normally active during the study period;
  • History of dermatologic disease on the hands, wrists or arms;
  • History of 3rd degree burns and/or skin grafts on the hands or wrists;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

  • Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.

    PMID: 33215698DERIVED

  • Turner RB, Fuls JL, Rodgers ND, Goldfarb HB, Lockhart LK, Aust LB. A randomized trial of the efficacy of hand disinfection for prevention of rhinovirus infection. Clin Infect Dis. 2012 May;54(10):1422-6. doi: 10.1093/cid/cis201. Epub 2012 Mar 12.

    PMID: 22412063DERIVED

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Ronald Turner, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 12, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

US(1)