Herpes Simplex LabialisNCT02157090
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.
A study testing Herpes Patch SOS (Hansaplast®) and Herpes vesicle patch of Compeed® in people with Herpes Simplex Labialis, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex Labialis
- What is being tested?
- Herpes Patch SOS (Hansaplast®) and Herpes vesicle patch of Compeed®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Carl Gustav Carus at the Technische Universität Dresden
Dresden, Saxony, 01307
About this study
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®)
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.
- Conditions
- Herpes Simplex Labialis
- Being tested
- Herpes Patch SOS (Hansaplast®), Herpes vesicle patch of Compeed®
- Keywords
- HSL of lips, perioral skin, duration of HSL symptoms not more than three days, not acyclovir or other cold sore therapies
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes Patch SOS (Hansaplast®)Other
Herpes vesicle patch of Compeed®Other
| Study group | Role | What they receive |
|---|---|---|
| Herpes Patch SOS (Hansaplast®) | Active comparator | Not described Receives: Other: Herpes Patch SOS (Hansaplast®) |
| Herpes vesicle patch of Compeed® | Active comparator | Not described Receives: Other: Herpes vesicle patch of Compeed® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
Secondary outcomes (9)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex LabialisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Beiersdorf AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157090
- Sponsor's protocol ID
- Herpes patch study 32583
- Status last verified
- Jun 2014
- First submitted
- 28 Oct 2010
- Last updated
- 5 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®)
- ClinicalTrials.gov ID
- NCT02157090
- Acronym / sponsor ID
- Herpes patch study 32583
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Beiersdorf AG
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herpes Patch SOS (Hansaplast®) | Active comparator | Other: Herpes Patch SOS (Hansaplast®) |
| Herpes vesicle patch of Compeed® | Active comparator | Other: Herpes vesicle patch of Compeed® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes Patch SOS (Hansaplast®) | Other | Herpes Patch SOS (Hansaplast®) |
| Herpes vesicle patch of Compeed® | Other | Herpes vesicle patch of Compeed® |
Primary outcome
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.
9 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herpes Patch SOS (Hansaplast®) and Herpes vesicle patch of Compeed® in people with Herpes Simplex Labialis, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study was the Subjects Global Assessment of Therapy (SGAT) at final visit.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.