Cold SorePhase 4NCT00820534
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
A Phase 4 study testing Penciclovir in people with Cold Sore, run by Novartis at 1 site in United Kingdom.
Trial summary
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cold Sore
- What is being tested?
- Penciclovir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Nov 2009
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be known to be a cold sore sufferer and presenting a prodromal stage with pain
- Sign the written informed consent form prior to enrolment in the trial;
- Be aged 18 to 75 years;
Who cannot join
- If female, are pregnant, planning pregnancy or lactating;
- Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
- Have already ongoing classical cold sore lesions at the baseline visit;
- Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
- Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
- Are known to be immunosuppressed (acquired, congenital or therapeutic);
- Have been involved in any investigational protocol within the 30 days prior to the trial;
- Have evidence or history of drug or alcohol abuse;
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Belfast Health and Social Care Trust, Royal Victoria Hospital
Belfast, BT12 6BA
About this study
Official title: A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
- Conditions
- Cold Sore
- Being tested
- Penciclovir, Placebo
- 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.
PenciclovirDrug
Penciclovir every 2 hours during waking hours for 96 hours
PlaceboDrug
Placebo every 2 hous during waking hours for 96 hours
| Study group | Role | What they receive |
|---|---|---|
| Penciclovir | Experimental | Penciclovir Receives: Drug: Penciclovir |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
Measured: 72 hours
Secondary outcomes (1)
Size of the Cold Sore
The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
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.
- Other trials for Cold SoreStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Lamey, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820534
- Sponsor's protocol ID
- FPP4-DE-401
- Status last verified
- Dec 2010
- First submitted
- 9 Jan 2009
- Last updated
- 20 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
- ClinicalTrials.gov ID
- NCT00820534
- Acronym / sponsor ID
- FPP4-DE-401
- Conditions
- Cold Sore
- Keywords
- cold sore
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Posted 19 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penciclovir | Experimental | Drug: PenciclovirPenciclovir |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be known to be a cold sore sufferer and presenting a prodromal stage with pain
- Sign the written informed consent form prior to enrolment in the trial;
- Be aged 18 to 75 years;
Key exclusion criteria (8 listed)
- If female, are pregnant, planning pregnancy or lactating;
- Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
- Have already ongoing classical cold sore lesions at the baseline visit;
- Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
- Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
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 |
|---|---|---|
| PenciclovirPenciclovir every 2 hours during waking hours for 96 hours | Drug | Penciclovir |
| PlaceboPlacebo every 2 hous during waking hours for 96 hours | Drug | Placebo |
Primary outcome
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
Time frame: 72 hours
Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).
1 secondary outcome
Size of the Cold Sore
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cold Sore
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Recruiting
Cold Vs Warm Water Immersion for DOMS Recovery
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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.
Philip Lamey principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Penciclovir in people with Cold Sore, run by Novartis at 1 site in United Kingdom.
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 3 inclusion and 8 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 20 Apr 2012. 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Jan 2011). 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?
Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore. (time frame: 72 hours). 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 20 Apr 2012.