Herpes LabialisPhase 2LipP1NCT02871492
Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
A Phase 2 study testing Pritelivir 5% w/w ointment and Zovirax® cream in people with Herpes Labialis, run by AiCuris Anti-infective Cures AG at 10 sites in United States.
Trial summary
Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. 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?
- Pritelivir 5% w/w ointment and Zovirax® cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Nov 2016to 16 Oct 2017
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men and women of any ethnic group aged ≥18 years ;
- Subjects should have experienced ≥4 recurrences of herpes labialis in the previous 12-months period;
- Subjects should have experienced prodromal symptoms in at least 50% of recurrent Herpes labialis (rHL) episodes and should have developed ulcerative lesions that have progressed through vesicle, ulcer, and crust stages in at least 50% of the episodes;
- Willingness not to use any topical application (such as cosmetics, lip balm, sunscreens etc…) other than the trial medication in the area of lesion development from start of prodromal symptoms to complete healing;
- Willingness not to use any systemic and topical anti-Herpes Simplex Virus (HSV) agent during the trial participation including prescription and over-the-counter (OTC) products;
- Willingness not to use any systemic, anti-inflammatory or analgesic agents from start of prodromal symptoms to healing;
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- Willingness to refrain from mechanical disruption (ie, scrubbing, lancing, shaving) of the prodromal area or lesion after start of treatment with trial medication until end of the trial participation;
- Women of child bearing potential and males must use adequate contraception;
- Subject must give written informed consent.
- Subjects with current lesion may be enrolled, but they must not treat the lesion present at screening/randomization with the trial medication; they should be instructed to wait for their next subsequent lesion
Who cannot join
- Known intolerance to pritelivir or any of the ointment ingredients;
- Known intolerance to Zovirax® Cream or any of the ingredients (ie, acyclovir, cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, and white petrolatum) or valacyclovir;
- Any skin conditions that could interfere with the assessment of herpes labialis recurrences (eg, eczema, psoriasis, acne etc…)
- Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial
- Pregnant and/or breastfeeding women
- Participation in any investigational drug trial within the last 30 days before randomization for this clinical trial
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- Previous treatment with pritelivir tablets
- Previous participation in a HSV vaccination Trial unless having received placebo.
- Clinically relevant ECG abnormalities (eg, QTc according to Fridericia: QTcF > 450 ms for males and QTcF > 470 ms for females; PR > 220 ms) at screening.
- Clinically relevant abnormalities in laboratory indices at screening which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
- Known chronic infections which in the opinion of the investigator might have an impact on the safety and evaluability of the subject.
- Evidence of active malignancy or immunodeficiency disease, or require chronic use of immunosuppressive drugs (eg, systemic steroids) or topical steroids, or chronically use antiviral medication with activity against HSV.
- HIV positive based on screening labs.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Akron, Ohio, 44311
Study site
Anderson, South Carolina, 29621
Study site
Cincinnati, Ohio, 45236
Study site
Edina, Minnesota, 55435
Study site
Greer, South Carolina, 29650
Study site
Pinellas Park, Florida, 33781
Study site
San Antonio, Texas, 78229
Study site
Santa Rosa, California, 95405
Study site
Scottsdale, Arizona, 85251
Study site
St Louis, Missouri, 63141
About this study
Official title: A Randomized, Double-blind, Multi-center, Three Arm (Pritelivir, Placebo and Zovirax®) Parallel Group, Comparative Trial to Assess the Efficacy and Safety of Pritelivir 5% w/w Ointment for the Treatment of Recurrent Herpes Labialis in Adults - LipP1
Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4 days.
After self-initiation of treatment with trial medication subjects will be assessed daily by the Investigator until complete healing for a maximum of 13 days.
Subjects will document application of trial medication and the status of their lesion in a diary. There will also be blood sampling, ECG measurement and physical examination performed at the investigational site.
- Conditions
- Herpes Labialis
- Being tested
- Pritelivir 5% w/w ointment, Pritelivir ointment matching placebo, Zovirax® cream
- Keywords
- HSV, pritelivir, herpes, herpes labialis, topical,
- 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.
Pritelivir 5% w/w ointmentDrug
Pritelivir ointment matching placeboDrug
Zovirax® creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Pritelivir 5% w/w ointment | Experimental | Topical treatment (20 applications), 5 times daily for 4 days Receives: Drug: Pritelivir 5% w/w ointment |
| Pritelivir ointment matching placebo | Placebo comparator | Topical treatment (20 applications), 5 times daily for 4 days Receives: Drug: Pritelivir ointment matching placebo |
| Zovirax® cream | Active comparator | Topical treatment (20 applications), 5 times daily for 4 days Receives: Drug: Zovirax® cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment
The Investigator assessed subjects for lesion stage at every visit as long as lesions were present from Visit 1 to the End of Trial Visit (Day 12± 1) as a maximum. Percentage of subjects with non-ulcerative lesions (i.e, scoring below 3) based on the Principal Investigators Assessment. Lesion stages were defined as follows: 1-Prodrome; 2a-Redness; 2b-Erythema-Redness; 3-Small Blister; 4-Ulcer; 5-Crust; 6-Drying up and healing; 0-Resolved
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start29 Nov 2016
- Primary completion29 Sep 2017
- Study completion16 Oct 2017
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiCuris Anti-infective Cures AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871492
- Sponsor's protocol ID
- AIC316-02-II-01
- Acronym
- LipP1
- Status last verified
- Jul 2021
- First submitted
- 5 Aug 2016
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Three Arm (Pritelivir, Placebo and Zovirax®) Parallel Group, Comparative Trial to Assess the Efficacy and Safety of Pritelivir 5% w/w Ointment for the Treatment of Recurrent Herpes Labialis in Adults - LipP1
- ClinicalTrials.gov ID
- NCT02871492
- Acronym / sponsor ID
- LipP1 / AIC316-02-II-01
- Conditions
- Herpes Labialis
- Keywords
- HSV, pritelivir, herpes, herpes labialis, topical,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- AiCuris Anti-infective Cures AGIndustry (pharma, biotech, devices)
- Collaborators
- Novella Clinical
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4 days.
After self-initiation of treatment with trial medication subjects will be assessed daily by the Investigator until complete healing for a maximum of 13 days.
Subjects will document application of trial medication and the status of their lesion in a diary. There will also be blood sampling, ECG measurement and physical examination performed at the investigational site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pritelivir 5% w/w ointment | Experimental | Drug: Pritelivir 5% w/w ointmentTopical treatment (20 applications), 5 times daily for 4 days |
| Pritelivir ointment matching placebo | Placebo comparator | Drug: Pritelivir ointment matching placeboTopical treatment (20 applications), 5 times daily for 4 days |
| Zovirax® cream | Active comparator | Drug: Zovirax® creamTopical treatment (20 applications), 5 times daily for 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy men and women of any ethnic group aged ≥18 years ;
- Subjects should have experienced ≥4 recurrences of herpes labialis in the previous 12-months period;
- Subjects should have experienced prodromal symptoms in at least 50% of recurrent Herpes labialis (rHL) episodes and should have developed ulcerative lesions that have progressed through vesicle, ulcer, and crust stages in at least 50% of the episodes;
- Willingness not to use any topical application (such as cosmetics, lip balm, sunscreens etc…) other than the trial medication in the area of lesion development from start of prodromal symptoms to complete healing;
- Willingness not to use any systemic and topical anti-Herpes Simplex Virus (HSV) agent during the trial participation including prescription and over-the-counter (OTC) products;
Key exclusion criteria (13 listed)
- Known intolerance to pritelivir or any of the ointment ingredients;
- Known intolerance to Zovirax® Cream or any of the ingredients (ie, acyclovir, cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, and white petrolatum) or valacyclovir;
- Any skin conditions that could interfere with the assessment of herpes labialis recurrences (eg, eczema, psoriasis, acne etc…)
- Any other condition which in the opinion of the Investigator would interfere with successful completion of this clinical trial
- Pregnant and/or breastfeeding women
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 |
|---|---|---|
| Pritelivir 5% w/w ointment | Drug | Pritelivir 5% w/w ointment |
| Pritelivir ointment matching placebo | Drug | Pritelivir ointment matching placebo |
| Zovirax® cream | Drug | Zovirax® cream |
Primary outcome
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment
Time frame: 13 days
The Investigator assessed subjects for lesion stage at every visit as long as lesions were present from Visit 1 to the End of Trial Visit (Day 12± 1) as a maximum. Percentage of subjects with non-ulcerative lesions (i.e, scoring below 3) based on the Principal Investigators Assessment. Lesion stages were defined as follows: 1-Prodrome; 2a-Redness; 2b-Erythema-Redness; 3-Small Blister; 4-Ulcer; 5-Crust; 6-Drying up and healing; 0-Resolved
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pritelivir 5% w/w ointment and Zovirax® cream in people with Herpes Labialis, run by AiCuris Anti-infective Cures AG at 10 sites 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 10 inclusion and 13 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Jul 2021). 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?
Efficacy Measured by Percentage of Subjects With Non-ulcerative Lesions Based on Principal Investigator's Assessment (time frame: 13 days). 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 13 Jul 2021.