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.

Herpes Simplex Labialis Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157090
• Other study ID #: Herpes patch study 32583
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: June 2, 2014
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2014
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Herpes Labialis
• Herpes Simplex
• Herpes Simplex Labialis

Intervention

Other:
• Herpes Patch SOS (Hansaplast®)

• Herpes vesicle patch of Compeed®

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus at the Technische Universität Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Beiersdorf AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary	Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)
Secondary	Blinded clinician global assessment (IGAT) at the end of therapy.
Secondary	Development of lesion size.
Secondary	The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.
Secondary	Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.
Secondary	Clinician-assessed time to complete healing from begin of the study.
Secondary	Time to complete healing of HSL after beginning of signs and symptoms.
Secondary	Assessment of the local compatibility by patient and by investigator.
Secondary	The severity and duration of subject-assessed individual signs and symptoms.