Herpes LabialisNCT01225341
Botulinum Toxin A for Herpes Labialis
A study testing onabotulinumtoxinA and Bacteriostatic normal saline in people with Herpes Labialis, run by DeNova Research at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- onabotulinumtoxinA and Bacteriostatic normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2012
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females between the ages of 18 and 64.
- Have herpes simplex virus 1 (HSV-1) with between 2-6 herpes labialis recurrences per year.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries
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- has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
- absence of an other physical condition according to the PI's discretion
- Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Who cannot join
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
- Active recurrence of herpes labialis.
- Botulinum toxin to the lower 1/3 of the face with the past 6 months.
- Significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure.
- Concurrent skin condition affecting area to be treated.
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- Prior surgery on the area to be treated within 3 months of initial treatment or during the study.
- History or evidence of keloids or hypertrophic scarring.
- Current use of antivirals for the treatment of herpes labialis within 2 weeks prior to initiation of treatment (e.g., acyclovir, valaciclovir, famciclovir, and penciclovir).
- Topical use of over-the-counter medications for the treatment or prevention of HSV-1 (e.g., Abreva).
- Subjects currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function.
- Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function or current facial palsy.
- Current history of chronic drug or alcohol abuse.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Subjects who, in the Investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability.
- Enrollment in any active study involving the use of investigational devices or drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, Crossover Study to Assess the Safety and Efficacy of Botulinum Toxin A Injections as a Preventative Measure for Herpes Labialis.
The purpose of this study is to determine the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.
- Conditions
- Herpes Labialis
- Being tested
- onabotulinumtoxinA, Bacteriostatic normal saline
- Keywords
- HSV-1, Herpes labialis, Cold sores, Fever blisters
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinADrug
Also called Botox
Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
Bacteriostatic normal salineOther
Also called Saline
Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA/placebo | Experimental | Patients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline. Receives: Drug: onabotulinumtoxinA; Other: Bacteriostatic normal saline |
| Bacteriostatic normal saline/ onabotulnimtoxinA | Placebo comparator | Patients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA. Receives: Drug: onabotulinumtoxinA; Other: Bacteriostatic normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Recurrence and Duration of Herpes Labialis Lesions
Days between last injection and outbreak onset \& Days between onset and recurrence
Measured: 12 months
Secondary outcomes (3)
Measurement of Lesion Size
Lesions will be measured in millimeters across the maximal lesion length in mm
Measured: 12 months
Pain Assessment
Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to the Visual Analog Scale for pain (VAS) by placing a straight line intersecting the pain line. The scale will be 10 cm long and the distance from start to mark will be measured in millimeters.
Score range is 0-10. Scores closer to 0 signify lower pain levels and scores closer to 10 signify high pain levels
Measured: During outbreak
Symptom Evaluation
Each day of a recurrence of herpes labialis, the subject will document his/her pain level in the diary according to a 4-point scale ((0) none, (1) mild, (2) moderate, (3) severe).
Scores closer to 0 indicate a more favorable outcome.
Measured: During outbreak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionJun 2012
Why it stopped: Too many patients withdrew/lost to follow up
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Steven H. Dayan, DeNova Research
- Investigators
- Steven H Dayan, MD, Principal investigator, DeNova Research/ Chicago Center for Facial Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225341
- Sponsor's protocol ID
- HSV-BOT-01-09
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2010
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled, Crossover Study to Assess the Safety and Efficacy of Botulinum Toxin A Injections as a Preventative Measure for Herpes Labialis.
- ClinicalTrials.gov ID
- NCT01225341
- Acronym / sponsor ID
- HSV-BOT-01-09
- Conditions
- Herpes Labialis
- Keywords
- HSV-1, Herpes labialis, Cold sores, Fever blisters
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too many patients withdrew/lost to follow up
- Enrolment
- 20 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Aug 2010 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Posted 21 Dec 2020
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 the efficacy and safety of Botulinum Toxin Type A as a preventative measure for Herpes Labialis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA/placebo | Experimental | Drug: onabotulinumtoxinA, Other: Bacteriostatic normal salinePatients will be injected every 3 months with onabotulinumtoxinA for a period of 12 months. At the 12 month visit, patients will receive injections of saline. |
| Bacteriostatic normal saline/ onabotulnimtoxinA | Placebo comparator | Drug: onabotulinumtoxinA, Other: Bacteriostatic normal salinePatients will be injected every 3 months with saline for a period of 12 months. At the 12 month visit, patients will receive injections of onabotulnimtoxinA. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or females between the ages of 18 and 64.
- Have herpes simplex virus 1 (HSV-1) with between 2-6 herpes labialis recurrences per year.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
- Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
- postmenopausal for at least 12 months prior to study drug administration
Key exclusion criteria (16 listed)
- Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
- Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
- Active recurrence of herpes labialis.
- Botulinum toxin to the lower 1/3 of the face with the past 6 months.
- Significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure.
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 |
|---|---|---|
| onabotulinumtoxinAAlso: BotoxBotox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle. | Drug | Bacteriostatic normal saline/ onabotulnimtoxinA, onabotulinumtoxinA/placebo |
| Bacteriostatic normal salineAlso: SalineStudy treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle. | Other | Bacteriostatic normal saline/ onabotulnimtoxinA, onabotulinumtoxinA/placebo |
Primary outcome
Measurement of Recurrence and Duration of Herpes Labialis Lesions
Time frame: 12 months
Days between last injection and outbreak onset \& Days between onset and recurrence
3 secondary outcomes
Measurement of Lesion Size
Time frame: 12 months
Pain Assessment
Time frame: During outbreak
Symptom Evaluation
Time frame: During outbreak
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Steven H Dayan, MD principal investigator
DeNova Research/ Chicago Center for Facial Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing onabotulinumtoxinA and Bacteriostatic normal saline in people with Herpes Labialis, run by DeNova Research 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 21 Dec 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2020). 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?
Measurement of Recurrence and Duration of Herpes Labialis Lesions (time frame: 12 months). 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 21 Dec 2020.