Efficacy Study of A Lotion to Prevent Common Colds
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects|
- Reduction of rhinovirus-induced common colds. [ Time Frame: 9 weeks ]
- Reduction of rhinovirus infections and reduction of common colds. [ Time Frame: 9 weeks ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|No Intervention: No treatment|
|Experimental: 3804-250A lotion||
3.2 ml applied topically after hand washing and at least every 3 hours while awake.
Rhinovirus infections are the most frequent cause of up to 80% of cold illness during the fall rhinovirus season. While viral upper respiratory tract infections are generally mild and self-limiting, 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 common colds consist primarily of symptomatic cold remedies that have only most effects on specific cold symptoms. 3804-250A is a topical treatment under investigation for the prevention of rhinovirus-associated colds by interruption of person-to-person transmission.
The study is a randomized trial conducted during a 9-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be randomly assigned to one of two treatment groups:
- AV Lotion or
- No Treatment control.
Subjects in the 3804-250A group will use the treatment on a defined schedule. The No Treatment control group will maintain their regular hand washing routine.
All subjects will record the presence of cold illness symptoms daily. Subjects will return to the study site weekly during the study for specimen collection for rhinovirus PCR, evaluation of irritation, review and clarification of study diary entries, for review and assessment of compliance, collection of adverse events and replenishment of study supplies. In addition, for the first five weeks of the study, subjects in the AV Lotion group will attend a second weekly compliance visits in which diaries and test product consumption will be assessed for compliance and collection of adverse events. Photographs of the hands will be taken for subjects who are withdrawn for skin irritation. The incidence of cold illness, rhinovirus-associated cold illness and rhinovirus infection will be compared between the treatment groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993759
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Ronald Turner, MD||University of Virginia|