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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
Sponsor:
Collaborator:
Devirex AG
Information provided by:
University of Zurich

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 5, 2009
Last Update Posted Date August 8, 2011
Study Start Date  ICMJE April 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2011)
Reducing the number of Herpes labialis relapse. [ Time Frame: June 2009 - Mai 2010 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
Number of Herpes labialis relapses. [ Time Frame: Two-monthly control visits. In case of Herpes relapse: four additional visits per relapse. On day 1, 5, 10 and 14 (each visit within 24h). ]
Change History Complete list of historical versions of study NCT00914745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2009)
  • Maximal Herpes lesion area (square Millimeter). [ Time Frame: Two-monthly control visits. In case of Herpes relapse: four additional visits per relapse. On day 1, 5, 10 and 14 (each visit within 24h). ]
  • Duration of Herpes relapse episode. [ Time Frame: Two-monthly control visits. In case of Herpes relapse: four additional visits per relapse. On day 1, 5, 10 and 14 (each visit within 24h). ]
  • Degree of pain (100mm visual analog scale) [ Time Frame: Two-monthly control visits. In case of Herpes relapse: four additional visits per relapse. On day 1, 5, 10 and 14 (each visit within 24h). ]
  • Safety and tolerability of HPBCD ointment. [ Time Frame: Two-monthly control visits. In case of Herpes relapse: four additional visits per relapse. On day 1, 5, 10 and 14 (each visit within 24h). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Place Controlled Study to Treat Recurrent Herpes Labialis.
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Recurrent Herpes Labialis
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00914745
Other Study ID Numbers  ICMJE ZU-HPB-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Kuendig, University Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Devirex AG
Investigators  ICMJE
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP