Herpes LabialisPhase 3NCT01257074
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
A Phase 3 study testing Acyclovir 50mg/g and Penciclovir 10mg/g in people with Herpes Labialis, run by EMS at 1 site in Brazil.
Trial summary
Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g. 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?
- Acyclovir 50mg/g and Penciclovir 10mg/g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Oct 2012
- 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
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
- No history of reaction to topical products;
Who cannot join
- Pregnancy or risk of pregnancy.
- Lactation
- Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
- Sunlight over exposure in the last 15 days.
- Any pathology or past medical condition that can interfere with this protocol.
- AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
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- Patients with immunodeficiency and/or immunosuppressive disease;
- Sunlight exposure in the last 15 days;
- Hypersensitivity to components of the formula;
- Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.
Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.
Read the detailed description
Study design:
- Double blinded non-inferiority prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 10 days
- 3 visits (days 1,5 and 10)
- Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
- Adverse events evaluation
- Conditions
- Herpes Labialis
- Being tested
- Acyclovir 50mg/g, Penciclovir 10mg/g
- Keywords
- Herpes Simplex
- Medical subject headings
- Herpes Labialis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir 50mg/gDrug
Cream, dose 5 times daily during 5 days
Penciclovir 10mg/gDrug
Cream, dose 5 times daily during 5 days
| Study group | Role | What they receive |
|---|---|---|
| Drug 1 | Experimental | Penciclovir 10mg/g Receives: Drug: Penciclovir 10mg/g |
| Drug 2 | Active comparator | Acyclovir 50mg/g Receives: Drug: Acyclovir 50mg/g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
Measured: Day 10
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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 posted9 Dec 2010 (estimated)
- Study startFeb 2012
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- More trials run by EMSThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavia Addor, MD, Principal investigator, Medcin Instituto da Pele Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257074
- Sponsor's protocol ID
- PENEMS1010
- Status last verified
- Mar 2013
- First submitted
- 6 Dec 2010
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis.
- ClinicalTrials.gov ID
- NCT01257074
- Acronym / sponsor ID
- PENEMS1010
- Conditions
- Herpes Labialis
- Keywords
- Herpes Simplex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Dec 2010 (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.
Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.
Detailed description
Study design:
- Double blinded non-inferiority prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 10 days
- 3 visits (days 1,5 and 10)
- Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug 1 | Experimental | Drug: Penciclovir 10mg/gPenciclovir 10mg/g |
| Drug 2 | Active comparator | Drug: Acyclovir 50mg/gAcyclovir 50mg/g |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
- No history of reaction to topical products;
Key exclusion criteria (10 listed)
- Pregnancy or risk of pregnancy.
- Lactation
- Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
- Sunlight over exposure in the last 15 days.
- Any pathology or past medical condition that can interfere with this protocol.
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 50mg/gCream, dose 5 times daily during 5 days | Drug | Drug 2 |
| Penciclovir 10mg/gCream, dose 5 times daily during 5 days | Drug | Drug 1 |
Primary outcome
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation
Time frame: Day 10
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 10
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 4 Mar 2013.
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.
Flavia Addor, MD principal investigator
Medcin Instituto da Pele Ltda
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 Acyclovir 50mg/g and Penciclovir 10mg/g in people with Herpes Labialis, run by EMS at 1 site in Brazil.
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 10 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 4 Mar 2013. 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 Brazil. 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.
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?
Efficacy will be evaluated by the proportion of subjects with non herpes labialis manifestation (time frame: Day 10). 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 4 Mar 2013.