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)
Verified date | May 2011 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Federal Office of Public Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2011 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 exclusion criteria may not be enrolled in the study: 1. Females with child bearing potential who are not using a reliable, medically accepted method of birth control (e.g. surgical, intrauterine contraceptive device, birth control pill, double barrier, hormone delivery systems such as implants or injectables, condoms or diaphragm (each in combination with contraceptive creams, foams, etc.). 2. Pregnant or breast feeding female, or women planning to become pregnant during the trial. 3. Medical history of immunosuppression by radiotherapy, chemo therapy, immunomodulatory drugs, or HIV. 4. Participation in another clinical study within 30 days prior to application of 2-HPßCD. 5. Medical history of any severe diseases like hepatitis, renal or liver dysfunction, cardiovascular, gastrointestinal, malignant tumor(s), or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator. 6. Intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of 2-HPßCD, or plan to take such drugs during the trial. 7. Use of anti-inflammatory medications and steroids during the course of the study. 8. Eczema herpeticatum or any history of other skin disease that would predispose to ec-zema herpeticatum. 9. Any abnormal perioral skin condition. 10. Known or suspected allergic or adverse response to the investigational product (2- HPßCD) or its excipients (PEG 400, and PEG 8000). 11. Inability to follow the study protocol. 12. Medical history of alcohol and/ or drug abuse within the previous 12 months before enrollment in the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Devirex AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reducing the number of Herpes labialis relapse. | June 2009 - Mai 2010 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03977792 -
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
|
Phase 2 | |
Completed |
NCT00248144 -
A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis
|
Phase 4 | |
Active, not recruiting |
NCT05098938 -
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
|
Phase 3 | |
Completed |
NCT01985321 -
Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
|
Phase 2 | |
Completed |
NCT03192306 -
Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for Episodic Treatment of Cold Sores
|
Phase 2 | |
Completed |
NCT01324466 -
A Multicenter Study of NB-001 in the Treatment of Recurrent Herpes Labialis (SHaRCS)
|
Phase 3 |