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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.

Information source: Technische Universität Dresden
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex Labialis

Intervention: Herpes Patch SOS (Hansaplast®) (Other); Herpes vesicle patch of Compeed® (Other)

Phase: N/A

Status: Completed

Sponsored by: Technische Universität Dresden

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.

Clinical Details

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 Labialis in Comparison to a Competitor's Product (Herpes Vesicle Patch of COMPEED®)

Study design: N/A

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: August 2009
Last updated: June 2, 2014

Page last updated: August 23, 2015

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