Herpes LabialisPhase 3NCT00361881
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
A Phase 3 study testing ME-609 in people with Herpes Labialis, run by Medivir at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- ME-609
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,443 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2007
- Phase
- Phase 3
- 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
- Generally good health
- History of recurrent herpes labialis with at last three episodes during the prior 12 months
Who cannot join
- Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
- Pregnant and/or nursing women
- Continuous daily treatment with pain medication
- Significant skin condition that occur in the area of herpes recurrences
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Caroline Research Center
Mt. Pleasant, South Carolina, 29464
About this study
Official title: A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.
Read the detailed description
This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.
- Conditions
- Herpes Labialis
- Being tested
- ME-609, acyclovir in ME-609 vehicle, Vehicle
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-609Drug
Cream, dose 5 times daily during 5 days.
acyclovir in ME-609 vehicleDrug
Dose 5 times daily for 5 days
VehicleDrug
Dose 5 times daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ME-609 Receives: Drug: ME-609 |
| 2 | Active comparator | Acyclovir in ME-609 vehicle Receives: Drug: acyclovir in ME-609 vehicle |
| 3 | Placebo comparator | Vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.
Measured: 5 days
Secondary outcomes (1)
Episode duration
Measured: until healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes LabialisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivir
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher M Hull, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361881
- Sponsor's protocol ID
- 609-04
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2006
- Last updated
- 18 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo B, Levin MJ, Tyring S, Spruance SL; ME-609 Study Group. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol. 2011 Apr;64(4):696.e1-11. doi: 10.1016/j.jaad.2010.08.012. Epub 2010 Sep 20.
PubMed 20851499
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis
- ClinicalTrials.gov ID
- NCT00361881
- Acronym / sponsor ID
- 609-04
- Conditions
- Herpes Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,443 participants (actual)
- Lead sponsor
- MedivirIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Aug 2006 (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.
The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.
Detailed description
This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ME-609ME-609 |
| 2 | Active comparator | Drug: acyclovir in ME-609 vehicleAcyclovir in ME-609 vehicle |
| 3 | Placebo comparator | Drug: VehicleVehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally good health
- History of recurrent herpes labialis with at last three episodes during the prior 12 months
Key exclusion criteria (4 listed)
- Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
- Pregnant and/or nursing women
- Continuous daily treatment with pain medication
- Significant skin condition that occur in the area of herpes recurrences
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 |
|---|---|---|
| ME-609Cream, dose 5 times daily during 5 days. | Drug | 1 |
| acyclovir in ME-609 vehicleDose 5 times daily for 5 days | Drug | 2 |
| VehicleDose 5 times daily for 5 days | Drug | 3 |
Primary outcome
Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage.
Time frame: 5 days
1 secondary outcome
Episode duration
Time frame: until healing
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 18 Aug 2008.
- Derived from this study: PubMed 20851499Hull CM, Harmenberg J, Arlander E, Aoki F, Bring J, Darpo B, Levin MJ, Tyring S, Spruance SL; ME-609 Study Group. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol. 2011 Apr;64(4):696.e1-11. doi: 10.1016/j.jaad.2010.08.012. Epub 2010 Sep 20.
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.
Christopher M Hull, MD 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 3 study testing ME-609 in people with Herpes Labialis, run by Medivir at 1 site in United States.
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 2 inclusion and 4 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 18 Aug 2008. 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 States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage. (time frame: 5 days). 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 NCT00361881, 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 18 Aug 2008.