Status:
COMPLETED
Place Controlled Study to Treat Recurrent Herpes Labialis.
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Devirex AG
Conditions:
Recurrent Herpes Labialis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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 millio...
Eligibility Criteria
Inclusion
- Inclusion criteria: Patients will be enrolled in the study if they fulfill the following inclusion criteria:
- 18 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.
- Exclusion criteria: Patients who fulfill any one of the following exclusion criteria may not be enrolled in the study:
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00914745
Start Date
April 1 2009
End Date
May 1 2011
Last Update
August 8 2011
Active Locations (1)
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1
Zurich, Switzerland