Recurrent Herpes Labialis Clinical Trial
Official title:
Single Center Phase I/II, Placebo Controlled, Randomized, Double-Blind Study to Treat Recurrent Herpes Labialis by Topical Treatment With Hydroxypropyl-Beta-Cyclodextrin-Ointment (HPßCD-20% Ointment)
About 80% of the worldwide population is positive on HSV antibodies. In the United States
the lifetime prevalence of recurrent herpes labialis is estimated at 20% to 40%, with
approximately 100 million episodes occurring in the country every year. In Switzerland about
70% of the adult population is positive on HSV-1 and about 20% is positive on HSV-2.
The Herpes simplex virus has a lipid bilayer (virus-envelope), which causes the
sensitiveness, to any kind of detergents. Within this bilayer cholesterol molecules are
integrated and play a crucial role in virus entry into host cells. In vitro experiments have
clearly shown that the depletion of cholesterol in HSV-envelope with 2- HPßCD has inhibited
the ability of the virus to infect host cells.
The aim of this clinical trial is to reduce the number of Herpes labialis relapse and to
provide patients with recurrent Herpes labialis a real benefit, concerning the simple
mechanism of action and the negligible side effects. Patients having problems in swallowing
the antiviral pills of standard treatment, will find with 2- HPßCD a drug, that just has to
be applied on the lips, which increases patient's quality of life tremendously.
- Trial with medicinal product
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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