Place Controlled Study to Treat Recurrent Herpes Labialis.

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914745

Enrollment

Registered

2009-06-05

Start date

2009-04-30

Completion date

2011-05-31

Last updated

2011-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Herpes Labialis

Brief summary

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

Interventions

DRUGOintment

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Patients will be enrolled in the study if they fulfill the following inclusion criteria: 1. 18 to 50 years old, 2. Medical history of Herpes labialis with lesions on the lips or in the perioral area (\<1cm from the border of the lips). 3. At least eight recurrences of labial herpes during the previous year before being en-rolled in the study. 4. Ability and willingness to participate in the study. 5. Voluntary written informed consent.

Exclusion criteria

Patients who fulfill any one of the following

Design outcomes

Primary

Measure	Time frame
Reducing the number of Herpes labialis relapse.	June 2009 - Mai 2010

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026