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.

NCT ID: NCT02157090

Last Updated: 2014-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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 Description

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Conditions

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Herpes Simplex Labialis

Study Groups

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Herpes Patch SOS (Hansaplast®)

Group Type ACTIVE_COMPARATOR

Herpes Patch SOS (Hansaplast®)

Intervention Type OTHER

Herpes vesicle patch of Compeed®

Group Type ACTIVE_COMPARATOR

Herpes vesicle patch of Compeed®

Intervention Type OTHER

Interventions

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Herpes Patch SOS (Hansaplast®)

Intervention Type OTHER

Herpes vesicle patch of Compeed®

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beiersdorf AG

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Carl Gustav Carus at the Technische Universität Dresden

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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Herpes patch study 32583

Identifier Type: -

Identifier Source: org_study_id

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