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Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762476
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Hill Top Research
TKL Research, Inc.
Information provided by (Responsible Party):
The Dial Corporation

Brief Summary:
The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.

Condition or disease Intervention/treatment Phase
Common Cold Drug: 3804-250A Drug: 3804-291 Phase 2

Detailed Description:

Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.

Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.

The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: 3804-291
  • topical
  • apply 2 pumps
  • apply at least every 4 hours or after hand washing

Experimental: 3804-250A Drug: 3804-250A
  • topical product
  • apply 2 pumps
  • apply at least every 4 hours or after hand washing

Primary Outcome Measures :
  1. The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. [ Time Frame: 10 weeks ]
    Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group

Secondary Outcome Measures :
  1. Rhinovirus Infections. [ Time Frame: 10 weeks ]
    The incidence of rhinovirus infections

  2. Rhinovirus-associated Colds [ Time Frame: 10 weeks ]
    The incidence of rhinovirus-associated cold illnesses.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy normal
  • good general health

Exclusion Criteria:

  • pregnancy
  • insulin dependent diabetes
  • daily smoker
  • skin disease on the hands/wrists
  • immunological disorders
  • occupation involving frequent handwashing
  • common cold symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762476

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United States, New Jersey
TKL Research, Inc.
Paramus, New Jersey, United States, 07652
United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
The Dial Corporation
Hill Top Research
TKL Research, Inc.
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Principal Investigator: Ronald B Turner, MD University of Virginia School of Medicine
Principal Investigator: Michael E Casser, MD TKL Research, Inc.
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Responsible Party: The Dial Corporation Identifier: NCT00762476    
Other Study ID Numbers: TM&R-0062-08-TXC
First Posted: September 30, 2008    Key Record Dates
Results First Posted: April 16, 2012
Last Update Posted: April 16, 2012
Last Verified: March 2012
Keywords provided by The Dial Corporation:
cold, common
Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases