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.

Study Overview
=================
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.

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®)

Conditions
-----------------
Herpes Simplex Labialis

Intervention / Treatment
-----------------
* Other: Herpes Patch SOS (Hansaplast®)
* Other: Herpes vesicle patch of Compeed®


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Herpes Patch SOS (Hansaplast®)<br> | Other: Herpes Patch SOS (Hansaplast®)<br> <br> |
| Active Comparator: Herpes vesicle patch of Compeed®<br> | Other: Herpes vesicle patch of Compeed®<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HSL of lips, perioral skin, duration of HSL symptoms not more than three days, not acyclovir or other cold sore therapies