Healthy Clinical Trial
Official title:
Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
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.
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:
1. AV Lotion or
2. 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subjects who are withdrawn for skin irritation.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.
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