NCT01225341TerminatedNot Applicable
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- DeNova Research
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measurement of Recurrence and Duration of Herpes Labialis Lesions
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females between the ages of 18 and
- •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
- •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.
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
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.
Intervention: onabotulinumtoxinA (Drug)
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.
Intervention: Bacteriostatic normal saline (Other)
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.
Intervention: onabotulinumtoxinA (Drug)
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.
Intervention: Bacteriostatic normal saline (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Measurement of Lesion Size(12 months)
- Pain Assessment(During outbreak)
- Symptom Evaluation(During outbreak)
Investigators
Steven H. Dayan
Medical Director
DeNova Research
Study Sites (1)
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