Back to resultsClinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product.
Primary Purpose
Herpes Simplex Labialis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Herpes Patch SOS (Hansaplast®)
Herpes vesicle patch of Compeed®
Sponsored by
About this trial
This is an interventional trial for Herpes Simplex Labialis focused on measuring HSL of lips, perioral skin, duration of HSL symptoms not more than three days, not acyclovir or other cold sore therapies
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
Sites / Locations
- University Hospital Carl Gustav Carus at the Technische Universität Dresden
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Herpes Patch SOS (Hansaplast®)
Herpes vesicle patch of Compeed®
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02157090
First Posted
October 28, 2010
Last Updated
June 2, 2014
Sponsor
Technische Universität Dresden
Collaborators
Beiersdorf AG
1. Study Identification
Unique Protocol Identification Number
NCT02157090
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Beiersdorf AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Labialis
Keywords
HSL of lips, perioral skin, duration of HSL symptoms not more than three days, not acyclovir or other cold sore therapies
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Herpes Patch SOS (Hansaplast®)
Arm Type
Active Comparator
Arm Title
Herpes vesicle patch of Compeed®
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Herpes Patch SOS (Hansaplast®)
Intervention Type
Other
Intervention Name(s)
Herpes vesicle patch of Compeed®
Primary Outcome Measure Information:
Title
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary Outcome Measure Information:
Title
Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)
Title
Blinded clinician global assessment (IGAT) at the end of therapy.
Title
Development of lesion size.
Title
The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.
Title
Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.
Title
Clinician-assessed time to complete healing from begin of the study.
Title
Time to complete healing of HSL after beginning of signs and symptoms.
Title
Assessment of the local compatibility by patient and by investigator.
Title
The severity and duration of subject-assessed individual signs and symptoms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital Carl Gustav Carus at the Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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.
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