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.

Technische Universität Dresden

Overview

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 Type

INTERVENTIONAL

Conditions

Herpes Simplex Labialis

Interventions

Herpes Patch SOS (Hansaplast®)OTHER

Herpes vesicle patch of Compeed®OTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Carl Gustav Carus at the Technische Universität Dresden

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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