Herpes LabialisPhase 1NCT01653509
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
A Phase 1 study testing Acyclovir patch in people with Herpes Labialis, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Acyclovir patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light
Trial locations and contacts
1 site in 1 country.
Germany1 site
proDERM Institute for Applied Dermatological Research GmbH
Hamburg, 22869
About this study
This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.
- Conditions
- Herpes Labialis
- Being tested
- Acyclovir patch, Placebo patch
- Keywords
- cold sore
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir patchDevice
Patch containing acyclovir
Placebo patchDevice
Patch without acyclovir
| Study group | Role | What they receive |
|---|---|---|
| Test patch | Experimental | Patch containing acyclovir applied to cold sore Receives: Device: Acyclovir patch |
| Placebo patch | Placebo comparator | Patch without acyclovir applied to cold sore Receives: Device: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Blood Flow
Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.
Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days.
Measured: Baseline to Day 10
Mean Change From Baseline in Temperature
Lesion thermographic parameters for TEV and MEV were analysed.
Measured: Baseline to Day 10
Mean Change From Baseline in Color Intensity of Lesions
The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).
Measured: Baseline to Day 10
Secondary outcomes (4)
Participant Assessment of Patch Comfort and Noticeability at Day 5
Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
- Today my sore felt completely protected
- Today my cold sores interfered with facial movements such as smiling, eating or drinking
- Today my cold sores interfered with my interaction with other people
- Today the patch disguised my cold sores
- Today I was bothered by the appearance of my cold sores
- Today my patch was easy to apply
- Today the patch covering my cold sores was bothersome
- Today the patches stayed in place on my cold sores until I removed them
- Today the patches were easy to remove from my lip or skin
Measured: Day 5
Participant Assessment of Patch Comfort and Noticeability at Day 10
Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:
- Today my sore felt completely protected
- Today my cold sores interfered with facial movements such as smiling, eating or drinking
- Today my cold sores interfered with my interaction with other people
- Today the patch disguised my cold sores
- Today I was bothered by the appearance of my cold sores
- Today my patch was easy to apply
- Today the patch covering my cold sores was bothersome
- Today the patches stayed in place on my cold sores until I removed them
- Today the patches were easy to remove from my lip or skin
Measured: Day 10
Participant Assessment of Symptom Intensity at Day 5
Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.
Measured: Day 5
Participant Assessment of Symptom Intensity at Day 10
Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labtec GmbH
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653509
- Sponsor's protocol ID
- E7411153
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2012
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Veltri J, Boon R, Bohling A, Wilhelm KP, Bielfeldt S. A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode. Dermatol Ther (Heidelb). 2021 Jun;11(3):983-994. doi: 10.1007/s13555-021-00531-x. Epub 2021 Apr 28.
PubMed 33913104
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
- ClinicalTrials.gov ID
- NCT01653509
- Acronym / sponsor ID
- E7411153
- Conditions
- Herpes Labialis
- Keywords
- cold sore
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Labtec GmbH
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test patch | Experimental | Device: Acyclovir patchPatch containing acyclovir applied to cold sore |
| Placebo patch | Placebo comparator | Device: Placebo patchPatch without acyclovir applied to cold sore |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Acyclovir patchPatch containing acyclovir | Device | Test patch |
| Placebo patchPatch without acyclovir | Device | Placebo patch |
Primary outcome
Mean Change From Baseline in Blood Flow
Time frame: Baseline to Day 10
Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique. Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days.
Mean Change From Baseline in Temperature
Time frame: Baseline to Day 10
Lesion thermographic parameters for TEV and MEV were analysed.
Mean Change From Baseline in Color Intensity of Lesions
Time frame: Baseline to Day 10
The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).
4 secondary outcomes
Participant Assessment of Patch Comfort and Noticeability at Day 5
Time frame: Day 5
Participant Assessment of Patch Comfort and Noticeability at Day 10
Time frame: Day 10
Participant Assessment of Symptom Intensity at Day 5
Time frame: Day 5
Participant Assessment of Symptom Intensity at Day 10
Time frame: Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33913104Veltri J, Boon R, Bohling A, Wilhelm KP, Bielfeldt S. A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode. Dermatol Ther (Heidelb). 2021 Jun;11(3):983-994. doi: 10.1007/s13555-021-00531-x. Epub 2021 Apr 28.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acyclovir patch in people with Herpes Labialis, run by GlaxoSmithKline 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?
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 16 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Blood Flow (time frame: Baseline to Day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01653509, which also lists 1 linked publication.
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 16 Jul 2014.