Place Controlled Study to Treat Recurrent Herpes Labialis.
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|ClinicalTrials.gov Identifier: NCT00914745|
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : August 8, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Herpes Labialis||Drug: Ointment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2011|
- Drug: Ointment
Each time about 1.5 cm ointment have to be applied on the upper lip and 1.5 cm on the lower lip, twice daily for prophylaxis for e period of 6 month.
- Reducing the number of Herpes labialis relapse. [ Time Frame: June 2009 - Mai 2010 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914745
|Study Director:||01 Studienregister MasterAdmins||UniversitaetsSpital Zuerich|