What Studies Show
- Viroxyn has been shown to greatly shorten the duration of cold sore episodes. In a “per protocol” analysis of a human clinical study, persons receiving the active drug healed in an average of about 3-1/2 days versus the literature value of 10 days. Many patients report pain relief within minutes of application.
- Study Particulars – Study QL01-1-01
The endpoint for healing was loss of scab and return to intact skin. Using this endpoint, the “Intent To Treat” (ITT) population for both groups showed a mean time to healing of 5.4 days (median = 4.4 days) (S.D. = 2.6 days) versus the literature value of 10 days.
When a "per-protocol" analysis was done the combined groups showed a mean time to healing of 3.6 days (median = 3.4 days) (S.D. = 1.1 days) versus the literature value of 10 days. The “per-protocol” analysis consists of data from patients who followed all study directions well, made all scheduled visits, and actually applied the study drug on all cold sores.
In this study, use of Viroxyn® was compared to the average natural history literature value of 10 days to healing (Essman, 2000). Patient population (n=41) consisted of a mix of naturally occurring cold sores(44%) and UV induced cold sores (56%). The “Intent To Treat” (ITT) population included patients who did not return to the study site. These patients were treated as “last observation carried forward”. The ITT population also included patients who developed additional disease (lesions) and did not treat with the study medication. The “per-protocol population” excluded these patients.
Reviewed: 10/09/03-A
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