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.
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedJune 5, 2014
June 1, 2014
5 months
October 28, 2010
June 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary Outcomes (9)
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.
- +4 more secondary outcomes
Study Arms (2)
Herpes Patch SOS (Hansaplast®)
ACTIVE COMPARATORHerpes vesicle patch of Compeed®
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technische Universität Dresdenlead
- Beiersdorf AGcollaborator
Study Sites (1)
University Hospital Carl Gustav Carus at the Technische Universität Dresden
Dresden, Saxony, 01307, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
June 5, 2014
Study Start
August 1, 2009
Primary Completion
January 1, 2010
Study Completion
June 1, 2010
Last Updated
June 5, 2014
Record last verified: 2014-06