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.
Not Applicable
Completed
- Conditions
- Herpes Simplex Labialis
- Interventions
- Other: Herpes vesicle patch of Compeed®Other: Herpes Patch SOS (Hansaplast®)
- Registration Number
- NCT02157090
- Lead Sponsor
- Technische Universität Dresden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Herpes vesicle patch of Compeed® Herpes vesicle patch of Compeed® - Herpes Patch SOS (Hansaplast®) Herpes Patch SOS (Hansaplast®) -
- Primary Outcome Measures
Name Time Method The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
University Hospital Carl Gustav Carus at the Technische Universität Dresden
🇩🇪Dresden, Saxony, Germany