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)
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 8, 2011
May 1, 2011
1.1 years
June 2, 2009
August 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Reducing the number of Herpes labialis relapse.
June 2009 - Mai 2010
Interventions
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.
Eligibility Criteria
You may qualify if:
- to 50 years old,
- Medical history of Herpes labialis with lesions on the lips or in the perioral area (\<1cm from the border of the lips).
- At least eight recurrences of labial herpes during the previous year before being en-rolled in the study.
- Ability and willingness to participate in the study.
- Voluntary written informed consent.
You may not qualify if:
- 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.).
- Pregnant or breast feeding female, or women planning to become pregnant during the trial.
- Medical history of immunosuppression by radiotherapy, chemo therapy, immunomodulatory drugs, or HIV.
- Participation in another clinical study within 30 days prior to application of 2-HPßCD.
- 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.
- 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.
- Use of anti-inflammatory medications and steroids during the course of the study.
- Eczema herpeticatum or any history of other skin disease that would predispose to ec-zema herpeticatum.
- Any abnormal perioral skin condition.
- Known or suspected allergic or adverse response to the investigational product (2- HPßCD) or its excipients (PEG 400, and PEG 8000).
- Inability to follow the study protocol.
- Medical history of alcohol and/ or drug abuse within the previous 12 months before enrollment in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Devirex AGcollaborator
Study Sites (1)
Unknown Facility
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 2, 2009
First Posted
June 5, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2011
Last Updated
August 8, 2011
Record last verified: 2011-05