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

This study has been completed.
Hill Top Research
TKL Research, Inc.
Information provided by (Responsible Party):
The Dial Corporation Identifier:
First received: September 26, 2008
Last updated: March 21, 2012
Last verified: March 2012
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 Intervention Phase
Common Cold Drug: 3804-250A Drug: 3804-291 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by The Dial Corporation:

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

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

Enrollment: 411
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00762476

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.
Principal Investigator: Ronald B Turner, MD University of Virginia School of Medicine
Principal Investigator: Michael E Casser, MD TKL Research, Inc.
  More Information

Responsible Party: The Dial Corporation Identifier: NCT00762476     History of Changes
Other Study ID Numbers: TM&R-0062-08-TXC
Study First Received: September 26, 2008
Results First Received: February 8, 2012
Last Updated: March 21, 2012

Keywords provided by The Dial Corporation:
cold, common

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on July 21, 2017