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Completed

NCT Number: NCT02157090

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.

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.

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Key information

Conditions

Herpes Simplex Labialis DNA Virus Infections Herpes Labialis Herpes Simplex Herpesviridae Infections Infections Lip Diseases Mouth Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Carl Gustav Carus at the Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herpes Patch SOS (Hansaplast®)

Other

Herpes vesicle patch of Compeed®

Other

Primary outcomes

  1. The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.

Secondary outcomes

  1. Number of patients with healed HSL lesions on day 5 and day 10 (assessed by clinician)

  2. Blinded clinician global assessment (IGAT) at the end of therapy.

  3. Development of lesion size.

  4. The number of study subjects with vesicles at onset of the study and at visit 2 and the final visit 3.

  5. Clinician-assessed lesion stage at onset of the study and at visit 2 and the final visit 3.

  6. Clinician-assessed time to complete healing from begin of the study.

  7. Time to complete healing of HSL after beginning of signs and symptoms.

  8. Assessment of the local compatibility by patient and by investigator.

  9. The severity and duration of subject-assessed individual signs and symptoms.

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Beiersdorf AG

Registry information

Official study 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®)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 5, 2014
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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