Clinical Trial: Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS (Hansaplast®) Based on Hydrocolloids Without Active Substances in the Treatment of Herpes Simplex

Brief Summary: Recent clinical studies showed, that a hydrocolloid patch is effective, well tolerated and comparable with aciclovir cream 5 % for the treatment of HSL lesions, while affording additional benefits of wound protection, discretion and relief of social embarrassment. The aim of the actual study was the clinical assessment of the effectiveness and safety of Hansaplast® SOS Herpes Patch (HPHP) in comparison to Compeed® Herpes Vesicle Patch (CHP) in treating HSL. Both products are CE-certificated and are available at the market for medical devices.

Detailed Summary:
Sponsor: Technische Universität Dresden

Current Primary Outcome: The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)
  • Blinded clinician global assessment (IGAT) at the end of therapy.
  • Development of lesion size.
  • The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.
  • Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.
  • Clinician-assessed time to complete healing from begin of the study.
  • Time to complete healing of HSL after beginning of signs and symptoms.
  • Assessment of the local compatibility by patient and by investigator.
  • The severity and duration of subject-assessed individual signs and symptoms.


Original Secondary Outcome: Same as current

Information By: Technische Universität Dresden

Dates:
Date Received: October 28, 2010
Date Started: August 2009
Date Completion:
Last Updated: June 2, 2014
Last Verified: June 2014