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CompletedNCT02157090Updated Jun 5, 2014

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.

An interventional study of Herpes Patch SOS (Hansaplast®) and Herpes vesicle patch of Compeed® in Herpes Simplex Labialis, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-05.

Sponsored by Technische Universität Dresden · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

Browse Herpes Simplex studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 237 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable

Study arms

  • Active comparator
    Herpes Patch SOS (Hansaplast®)

    Other: Herpes Patch SOS (Hansaplast®)

  • Active comparator
    Herpes vesicle patch of Compeed®

    Other: Herpes vesicle patch of Compeed®

Interventions

  • OtherHerpes Patch SOS (Hansaplast®)
  • OtherHerpes vesicle patch of Compeed®
06

What researchers measure

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.

07

Study locations

1 site
  • University Hospital Carl Gustav Carus at the Technische Universität Dresden
    Dresden, Saxony 01307, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02157090
Lead sponsor
Technische Universität Dresden
Collaborators
Beiersdorf AG
Responsible party
Sponsor
First posted
Jun 5, 2014
Start date
Aug 2009
Primary completion
Jan 2010
Completion
Jun 2010
Last update
Jun 5, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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