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.

June 2, 2014 updated by: Technische Universität Dresden

Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS (Hansaplast®) Based on Hydrocolloids Without Active Substances in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product (Herpes Vesicle Patch of COMPEED®)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • University Hospital Carl Gustav Carus at the Technische Universität Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • with a history of recurrent HSL of the lips and/or perioral skin
  • lesions typically manifesting as classical lesions
  • duration of HSL symptoms not more than three days
  • haven´t used acyclovir or other cold sore therapies

Exclusion Criteria:

  • pregnancy
  • lactating women
  • women of child-bearing age without medically secured contraceptions
  • topical or systemic therapy with analgesic
  • anti-inflammatory or antiviral agents within the last 2 weeks
  • topical therapy within the treatment area
  • systemic therapy with cytostatics or immunosuppressants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Herpes Patch SOS (Hansaplast®)
Other: Herpes Patch SOS (Hansaplast®)
Active Comparator: Herpes vesicle patch of Compeed®
Other: Herpes vesicle patch of Compeed®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Beiersdorf AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Herpes patch study 32583

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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