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®)

Technische Universität Dresden1 site in 1 countryAugust 2009

ConditionsHerpes Simplex Labialis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Herpes Simplex Labialis
Sponsor: Technische Universität Dresden
Locations: 1
Primary Endpoint: The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

June 2010

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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